WO2001095891A2

WO2001095891A2 - Method for treating dehydration and a composition therefor

Info

Publication number: WO2001095891A2
Application number: PCT/IB2001/000984
Authority: WO
Inventors: Harris B. Wright; Jason T. Lewis
Original assignee: Stockhausen Gmbh & Co. Kg
Priority date: 2000-06-15
Filing date: 2001-06-05
Publication date: 2001-12-20
Also published as: WO2001095891A3; AU5870901A

Abstract

Described is a method of treating dehydration in a warm-blooded vertebrate animal, and a composition useful therefor. The method involves administering to the animal a treatment effective amount of a superabsorbent polymer. Also described is a composition for treatment of dehydration in a warm-blooded vertebrate animal, wherein the composition contains a superabsorbent polymer having an additive agent admixed therewith.

Description

METHOD FOR TREATING DEHYDRATION

AND A COMPOSITION THEREFOR

Technical Field The present invention relates to a method for treating dehydration in animals. Also, the present invention relates to a composition for treating dehydration in animals. More particularly, the invention relates to treating dehydration in warm-blooded vertebrates, i.e. birds and/or mammals (including humans), wherein the dehydration has resulted from pathogens, nutritional factors, environmental factors, and/or physiological disorders, with a superabsorbent polymer.

Definitions of Abbreviations

Abbreviation Definition

C centigrade cm centimeter

DD bird died on its own

DI deionized

X-linked cross-linked

X-linking cross-linking

F female g gram hr hour kg kilogram

LB bird was sacrificed to examine organs as described in the protocol

M male μmol micromole mg milligram ml milliliter mm millimeter min minute

NA not applicable SAP superabsorbent polymer, a polymer that absorbs over 20 times its weight in water

VFA'S volatile fatty acids wt weight

Background Art

SAPs, namely highly water-swellable polymers, typically are prepared from an aqueous mixture of monomers. Usually, one or more networkX-linking agents are incorporated into the monomer mixture. After the polymerization and X-linking have ended, the viscous resultant is dried and subjected to mechanical grinding to create a desired particle size distribution.

SAPs are made by two polymerization methods, namely the solvent or solution polymerization method and the inverse suspension or emulsion polymerization method.

As is well known, SAPs are used in various absorbent articles, due to the ability of the SAPs to absorb aqueous liquids in a ready manner. For instance, well known uses for SAPs include use in sanitary articles (i.e., diapers, incontinence garments, etc.), in a sealing composite between concrete blocks that make up the wall of underwater tunnels, and in tapes for water blocking in fiber optic cables and power transmission cables.

A good discussion ofthe methods for making SAP particles can be seen in U.S. Patent No. 5,409,771 , issued April 25, 1995, to Dahmen and Mertens, assignors to Chemische Fabrik Stockhausen GmbH. More specifically, this patent mentions that SAP particles are generally network X-linked polyacrylic acids or network X-linked starch-acrylic-acid-graft-polymers, the carboxyl groups of which are partially neutralized with sodium hydroxide or caustic potash, and that such SAP particles may be surface X-linked, such as with an alkylene carbonate.

The following patents also describe making SAPs. U.S. Patent No. 5,264,471 , issued November 23, 1993, to Chemlir, U.S. Patent No.5,340,853, issued August 23, 1994 to Chemlir and Klimmek, U.S. Patent No. 5,721 ,295, issued February 24, 1998 to Brϋggemann, Gϋnther, and Klimmek, U.S. Patent No. 5,733,576, issued March 31 , 1998, to Chemlir, U.S. Patent No. 5,736,595, issued April 7, 1998, to Gϋnther, Klimmek, and Brϋggemann, and U.S. Patent No. 5,847,031 , issued December 8, 1998, to Klimmek, Gϋnther, and Brϋggemann. All 6 patents are assigned to Chemische Fabrik Stockhausen GmbH.

Of interest is U.S. Patent No. 5,182,299, issued January 26, 1993, to Gullans and Heilig, assignors to Brigham and Women's Hospital of Boston, Massachusetts. More particularly, this patent involves a method of treating an osmotic disturbance in an animal, such as a rabbit, by administering to the animal an organic osmolyte selected from polyols, methylamines, and amino acids. The osmotic disturbances described are hyponatremia, chronic hyponatremia, central pontine myelinolysis associated with hyponatremia, osmotic disturbances associated with renal dialysis, diabetic ketoacidosis, hyperglycemic hyperosmolar coma, acute hypernatremia, chronic uremia, chronic hypernatremia, including accidental salt loading in high sodium dialysis or baby formula, diabetes insipidus, diabetes melitus, alcoholism-related dehydration, dehydration from other causes, and AIDS.

Of further interest is that betaine has been investigated forthe treatment of diarrhea in chickens, as reported in U.S. Patent No. 5,516,798, issued May 14, 1996, to Ferket, assignor to North Carolina State University of Raleigh, North Carolina. This patent also mentions that betaine was previously investigated for treating chickens for hemorrhage of the hock and for growth enhancement of chickens. Also of interest is U.S. Patent No. 4,595,583, issued June 17, 1986, to

Eckenhoff et al., assignors to Alza Corporation. This patent describes a dispensing device for delivering a beneficial agent. The device includes (1) a semipermeable housing defining an internal space, (2) a dense member in the space, (3) a heat responsive composition containing a beneficial agent in the space, (4) an expandable member (i.e., a hydrogel) in the space, and (5) a passageway in the semipermeable housing for delivering the beneficial agent from the dispensing device. The hydrogel possesses the ability to imbibe a fluid and thus is water swellable. The materials used for forming the swellable, expandable hydrogel are polymeric materials neat, and polymeric materials blended with osmotic agents that interact with water ora biological fluid, absorb the fluid and swell or expand to an equilibrium state. The polymer exhibits the ability to retain a significant fraction of imbibed fluid in the polymer molecular structure. The polymers in a preferred embodiment are gel polymers that can swell or expand to a very high degree, usually exhibiting a 2 to 50 fold volume increase. The swellable, hydrophilic polymers, also known as osmopolymers, can be non X-linked or lightly X-linked. The X-linking can be covalent or ionic bonds with the polymer possessing the ability to swell in the presence of fluid, and when X-linked, it will not dissolve in the fluid. The polymer can be of plant, animal, or synthetic origin. Polymeric materials described as useful include poly(hydroxyalkyl methacrylate) having a molecular weight of from 5,000 to 5,000,000; poly(vinylpyrrolidone) having a molecular weight of from 10,000 to 360,000; anionic and cationic hydrogels; poly(electrolyte) complexes; poly(vinyl alcohol) having a low acetate residual; a swellable mixture of agar and carboxymethyl cellulose; a swellable composition comprising methyl cellulose mixed with a sparingly X-linked agar; a water-swellable copolymer of maleic anhydride with styrene, ethylene, propylene, or isobutylene; water swellable polymer of N-vinyl lactams; and the like.

Lastly, of background interest is U.S. Patent No. 5,930,949, issued August 3, 1999, to Tsujimoto, Sato, and Matsushita, assignors to Takii Shubyo Kabushiki Kaisha. This patent describes hydration of seeds with partially hydrated superabsorbent polymer particles. The disclosures of all patents and published patent applications that are mentioned are incorporated by reference. Objects and Summary of the Invention The present invention provides a method of treating dehydration in a warm-blooded vertebrate animal comprising administering to the animal a treatment effective amount of a SAP. Optionally, the SAP may be hydrolyzed and/or may have admixed with it an additive agent.

Also, the present invention provides a dehydration treatment composition for treating dehydration in a warm-blooded vertebrate animal comprising a SAP that has admixed with it an additive agent. Optionally, the

SAP may be hydrolyzed. The concentration of the SAP administered to the animal, sufficient to provide a treatment effective amount, should be such that a daily dose provides between about 0.05g to about 2.0g of SAP per kg of body weight ofthe animal.

Thus, it is an object of the invention to stop or to alleviate dehydration in animals, particularly in young animals that are infants or children, whereby the young animals can achieve the proper weight gain during growth into adulthood.

More particularly, it is a further object of the invention to stop or to alleviate dehydration in birds, especially fowl such as turkeys, chickens, ducks, geese, guinea fowl, and the like, when they are young so that their maturity into adulthood is more efficacious. As a result, their maturity into adulthood occurs with fewer health-related problems and better feed conversion such that they can be more quickly sent to market for slaughter to produce high quality meat products.

Additionally, in connection with sending the animals to market for slaughter, the transportation causes stress which can cause diarrhea, which can result in dehydration. Thus, it is a further object to treat animals with a SAP just prior to slaughter in order to stop or to alleviate dehydration induced by such stress and consequently to reduce carcass/meat contamination by fluid and fecal matter, particularly for fowl. Hence, an advantage of the invention is that when the dehydration is stopped or alleviated, less contamination of equipment, the animal's pen, orthe animal itself, by fecal matter occurs, whether at the farm, during transport to a slaughterhouse, or during processing at the slaughterhouse.

Some ofthe objects and advantages ofthe invention having been stated above, other objects and advantages will become evident as the description proceeds, when taken in connection with the accompanying Laboratory Examples as best described below.

Detailed Description of the Invention The present invention involves a method for treating dehydration in an animal that is a warm-blooded vertebrate. Additionally, the invention also involves a composition useful forthe treatment of dehydration in warm-blooded vertebrate animals. Therefore, the invention concerns mammals and birds.

Contemplated is the treatment of mammals such as humans, as well as those mammals of economical importance (animals raised on farms for consumption by humans) and/or social importance (animals kept as pets or in zoos) to humans, for instance, carnivores otherthan humans (such as cats and dogs), swine, ruminants (such as cattle, oxen, sheep, giraffes, deer, goats, bison, and camels), and horses.

Also, contemplated is the treatment of birds, which can include those kinds of birds kept in zoos. However, particularly contemplated is the treatment of fowl, and more particularly domesticated fowl, i.e., poultry, such as turkeys, chickens, ducks, geese, guinea fowl, and the like, as they are also of economical importance to humans.

Therefore, especially important is the treatment of dehydration in livestock, including, but not limited to, swine, ruminants, horses, poultry, and the like.

More particularly, a treatment effective amount of a SAP is administered to the warm-blooded vertebrate animal. Thus, the invention comprises administration of a SAP in concentrations calculated to provide the animal being treated with the appropriate milieu to provide control or cessation of dehydration. The present invention should be useful in the treatment of dehydration in animals resulting from diarrhea that is caused by pathogens (i.e., parasites, bacteria, protozoa, and viruses, including toxic agents in food created by spoiling of the food), nutritional factors (i.e., excess mineral salts, excess protein, allergic agents in food, undigestible food components, or poor quality ingredients in food), environmental factors that act as stressors or pollutants (i.e., heat, chilling, shipmentof animals, or toxins such as from air and/or water pollution), and/or physiological disorders such as those of the digestive tract, pulmonary/circulatory system, liver, kidneys, and/or pancreas, or resulting from any other factors that cause dehydration.

The SAPs in the present invention are organic polymers which are solid and hydrophilic, absorbing over 20 times their weight in water. Generally, these SAPs are chosen from acrylate polymers (which is intended to include copolymers and terpoiymers). These SAPs are typically in a powder or flake form (i.e., particulates), adapted to be blended and/or agglomerated. SAPs are generally nontoxic, biodegradable, and relatively inexpensive to buy or to produce.

Although SAPs that are acrylamide polymers, copolymers, and terpoiymers are also known, such as that sold under the trademark STOCKOSORB ® by Stockhausen, the SAP composition employed in the present invention should be free of SAPs that are acrylamide polymers, copolymers, and/or terpoiymers. The reason is that such SAPs can undergo a chemical reaction in the digestive tract of the treated animal and produce reaction products that are toxic. The toxicity could be to the treated animal, or to a subsequent animal that eats the treated animal. For instance, the treated animal could be a chicken, which could be slaughtered then cooked, and subsequently eaten by a human.

Suitable acrylate superabsorbent polymers may be, for example, acrylate polymers; alkali metal acrylate copolymers; propenenitrile homopolymers, alkali metal salts; polymers of propenamide and propenoic acid, alkali metal salts; acrylonitrile copolymers; starch graft copolymers and terpoiymers thereof; and combinations thereof. All of these are designed to be hydrophilic, absorbing over 20 times their weight in water. The resulting hydrophilic polymers can absorb from over 100 to greater than about 5000, more typically over 500 to about 1 ,000, times their own weight in water (measured using distilled water, pH 7.5, 25° C, 760 mm Hg, absorption within about 30 seconds). However, the absorption or swelling capacity and absorption or swelling time typically varies with each specific SAP.

One class of SAPs includes combinations of a starch and organic monomers, oligomers, polymers, copolymers or terpoiymers. They may be manufactured in a variety of well known ways, and can be, for example, the product of grafting corn starch (amylopectin) with acrylonitrile (an acrylic monomer or oligomer). Such SAPs are described in U.S. Patent Nos. 4,818,534, 4,983,389, 4,983,390, 4,985,251 , 5,567,430, and 5,824,328, all to Levy, assignor to Lee County Mosquito Control District, subsequently assigned to Stockhausen GmbH. The SAPs can also be propenoic or acrylonitrile-base polymers or copolymers or terpoiymers that also show superabsorbency properties.

Non-limiting specific examples of SAPs which are particularly useful include:

(1) X-linked polyacrylate (GROGEL™ a trade name of MS Bioscience, a division of Milk Specialties)

(2) hydrolyzed starch-polyacrylonitrile (TERRA-SORB™);

(3) 2-propenenitrile, homopolymer, hydrolyzed, sodium salt or poly(2-propenamide-co-2-propenoic acid, sodium salt), (WATER LOCK® Superabsorbent Polymer G-100);

(4) starch-g-poly (2-propenamide-co-2-propenoic acid, sodium salt), (WATER LOCK® Superabsorbent Polymer A-100);

(5) starch-g-poly (2-propenamide-co-2-propenoic acid, sodium salt), (WATER LOCK® Superabsorbent

Polymer A-200); (6) starch-g-poly (2-propenamide-co-2-propenoicacid, potassium salt), (WATER LOCK® Superabsorbent Polymer B-204);

(7) poly (2-propenamide-co-2-propenoic acid, sodium salt), (WATER LOCK® Superabsorbent Polymer

G-400);

(8) poly-2-propenoic acid, sodium salt (WATER LOCK® Superabsorbent Polymer J-500);

(9) starch-g-poly (acrylonitrile) (GENERAL MILLS® SGP);

(10) starch acrylonitrile copolymer (SUPER SORB/AG SORBENT);

(11 ) X-linked polyacrylate (FAVOR® sold by Stockhausen).

The SAP may be administered to the animal by various oral forms, for instance as a tablet, capsule, bolus, or particulate that is swallowed. Optionally, the oral form may be admixed with human food and/or animal feed. The SAP should be administered as a water-swelled suspension (i.e., hydrolyzed SAP), which is very suitable, since otherwise, sufficient drinking water should be provided to the animal to hydrolyze the SAP. A composition of hydrolyzed SAP should contain about 0.5% to about 15%, more preferably about 1 % to about 12% of SAP by weight based on the weight of the composition. If the hydrolyzed composition is not all immediately consumed, but rather eaten over an hour or two, for instance, then drinking water should also be provided as some of the water may evaporate out of the hydrolyzed composition that is laying around and eaten later.

A suitable amount of SAP for administration to the animal should range from about 0.05 gram to about 2.0 g per kg of body weight of the animal per day, more preferably from about 0.10 g to about 1.3 g per kg of body weight of the animal per day, and even more preferably from about 0.25 g to about 1.0 g per kg of body weight ofthe animal per day. Of course, the amount can vary depending on the severity of the dehydration and/or the age of the animal. Although the SAP may be administered free of any additive agents, it is also contemplated that an additive agent, for instance, various excipients (such as food coloring), carriers, surfactants, nutriments (such as vitamins, lactose, or electrolytes), growth enhancers (such as hormones or steroids), medicaments (such as vaccines), microbial control agents, prebiotics (such as fructo oligosaccharide), probiotics, competitive exclusion cultures, and combinations thereof, may be present, admixed together in composition with the SAP.

A suitable microbial control agent is sold under the trade name PREEMPT by MS Bioscience, Dundee, Illinois, United States of America. Specifically, PREEMPT is a blend of 29 bacteria, including at least one Lactobacillus, useful for the control of Salmonella in chickens. The bacteria blend is described in U.S. Patent No. 5,308,615, issued May 3, 1994, to DeLoach, Corrier, and Hinton, U.S. Patent No. 5,340,577, issued August 23, 1994, to Nisbet, Corrier, and DeLoach, U.S. Patent No. 5,478,557, issued December 26, 1995, to Nisbet, Corrier, and DeLoach, and U.S. Patent No. 5,604,127, issued February 18, 1997, to Nisbet, Corrier, and DeLoach. All 4 patents are assigned to the United States of America as represented by the Secretary of Agriculture. As stated in these patents, a lactose supplemented diet for chickens increases the acidity ofthe cecal contents and thus enhances Salmonella colonization resistance by increasing the bateriostatic action of short chain volatile fatty acids (VFA'S), such as acetic, propionic, valeric and butyric acids, produced by normal intestinal bacteria. Hence, effectiveness of PREEMPT that is administered to chickens is determined by analyzing the cecal contents for VFA'S.

As described in the Laboratory Examples below, SAPs, particularly GROGEL, have been found to be especially useful in the treatment of dehydration in chickens. Thus, as set out in the Laboratory Examples below, treatment of chickens with SAP to control or to stop dehydration was investigated. LABORATORY EXAMPLES

In Examples I, II, and III below, the SAP employed was X-linked polyacrylate copolymer (GROGEL) and the additive was a microbial control agent (PREEMPT). Testing for VFA'S was conducted as described in the above-noted 4 patents assigned to the United States of America as represented by the Secretary of Agriculture.

EXAMPLE I (treatment of male and female chickens with SAP) During an 8-week study, three different groups of chicks (each group with 26 males and 26 females) were treated.

The chicks in two of the groups were treated by giving them DI water having GROGEL dispersed in it. More particularly, GROGEL (CAS Registry Number 166164-74-5) was hydrolyzed, and the resultant composition was administered by gavage to day-old chicks. This X-linked polyacrylate copolymer is hereinafter referred to as SAP. The day-old chicks in the third group, namely the control group, were treated by gavage with DI water. Deaths were observed to determine any differences for those who received GROGEL as compared to those who received only DI water.

More specifically, the three experimental groups are described as follows.

High-dose group (designated as group 1 in Table 1 below)

Fifty-two (52) day-old chicks (26 males and 26 females) comprised the high-dose group for this study. Each of these chicks received two 3-gram doses of hydrolyzed SAP (for a total dose of 6 grams) on day 1 of the study. These two doses were administered 4 hours apart. This divided dosing schedule was used in the high-dose group because a crop of day-old chicks is not large enough to accommodate a 6-gram bolus dose of hydrolyzed SAP. A mass of 0.10 gram of dry SAP, when completely hydrolyzed with DI water, yielded 6 grams of hydrolyzed SAP. Any animals regurgitating the dose were noted. Assuming a starting chick weight of 40 grams, the associated SAP dose (on a dry weight basis) was 2.50 grams SAP/kg body weight. This dose of SAP was specifically selected to be twice that administered in the below- described low-dose group.

Control group (designated as group 2 in Table 1 below) Fifty-two (52) day-old chicks (26 males and 26 females) comprised the control group for this study. Each ,of these chicks received two 3-gram doses of DI water by gavage on the first day ofthe study (for a total dose of 6 grams), and thus served as the vehicle control for this study. These two doses were given 4 hours apart to mimic the dosing schedule in the high-dose group. Except for the fact that these animals were dosed with only DI water, they were treated identically to those animals in the two treatment groups.

Low-dose group (designated as group 3 in Table 1 below)

Fifty-two (52) day-old chicks (26 males and 26 females) comprised the low-dose group for this study. Each of the chicks in this dose group was gavaged with a single dose of 3 grams of hydrolyzed SAP on the first day of the study. A mass of 0.05 gram of dry SAP, when completely hydrolyzed with DI water, yields 3 grams of hydrolyzed SAP. Any animals regurgitating the dose were noted. Assuming a starting chick weight of 40 grams, the associated SAP dose (on a dry weight basis) was 1.25 grams SAP/kg body weight. This SAP dose was selected for this study because based on its intended use, an intake of 0.05 gram of dry SAP per chick was expected.

General study protocol Prior to study initiation, chicks were randomly assigned to one of the three experimental groups described above. Chicks in all experimental groups were monitored daily during their typical grow-out period (approximately 8 weeks). During this grow-out period, all animals in all experimental groups had ad libitum access to feed and water. Daily observations were made for mortality and/or morbidity. Necropsies were performed on any chicks that died during the study. Interim sacrifices and necropsies (1 chick of each sex per treatment group) were performed at 1 , 2, 4, and 6 weeks. AH surviving animals were sacrificed and necropsied at the end ofthe study. Collected data included mortality, weight gain, and evidence of disease or any other gross abnormality.

The necropsy procedure included the following: macroscopic examination involving the thoracic and visceral cavities; examination of the major organs, including oviducts; and opening and examining the stomach and representative sections of the gastrointestinal tract. Gross lesions were preserved in buffered formalin (or equivalent tissue preservative) and held for possible future microscopic examination (histology). The results of the study on the three groups of chicks are summarized in Table I below.

TABLE I

GROUP 1 AVERAGE BODY WEIGHT (a)

(CHICK

NUMBER and MALE DAY DAY DAY DAY DAY DAY or FEMALE) 0 1 2 3 4 5

1 M 48.2 58.6 70.8 86.6 102.5 108.5

2M 51.6 59.2 72.6 91.8 112.1 115.8

3M 49.9 56.4 71.2 88.6 104.6 113.4

4M ^' 48.6 62.2 73.4 95.3 110.2 115.3

5M 50 59.8 70.2 83 101.1 99.6

6M 41.7 50 59 74.4 87.1 100.9

7M 57 60.2 69 85.4 100.3 107

8M 60.4 69.8 82.8 100.8 125.8 120.5

9M 47.8 59.4 75 90.2 106.1 117.2

lO LO TABLE I (CONTINUED.

GROUP 1 AVERAGE BODY WEIGHT (g)

(CHICK NUMBER and MALE DAY DAY DAY DAY DAY DAY or FEMALE) 0 1 2 3 4 5

1F 49.5 55.8 64.4 71.8 88.6 99.1

2F 56.4 63.2 72.6 90.2 109.5 115.6

3F 52.8 62.2 72.6 90.6 105.6 114.4

4F 56.4 63 79.8 99.4 116.1 115.2

5F 53.2 59.4 70.4 82.2 101.8 106.9

6F 50.6 57.2 73.6 93.8 109.9 113.9

7F 46.1 55 66.8 81.4 93.9 95.8

8F 51 55.6 61.4 75.4 86.9 91.8

TABLE I (CONTINUED)

GROUP 1 AVERAGE BODY WEIGHT (g)

(CHICK

NUMBER and MALE DAY DAY DAY DAY DAY DAY or FEMALE) 6 7 14 21 28 35

1M 128.1 142.5 439 911.3 1507 2150

2M 133.4 153.8 420 848.1 1453.2 1950

3M 132.6 150.3 438.9 905.6 1536.5 2150

4M 147.7 171.4 535.2 913.9 1620 2250

5M 128.7 143.9 376

6M 123.6 145 445.2 944.6 1630.6 2350

7M 128.7 143.1 347.7 670.8 1217 1750

8M 152.1 175.2 471.6 964 1720.9 2450

9M 140.9 167.3 476.2 999.1 1648.3 2000

O

I^s--

CN I^s- rt CO σ LO oo "St CM 00

CM od I-: σi CO rt d CD CN o LO I^s- 00 CM "St cdo CM

LO ^•Irt "Sf rt CO rt rt CO "St

^•st r CN .,_ I^s-; I^s- <3> LO LO CO CD oq 00 'St σ. CD CN oo ^■st rt CM CD CM I^s- rt CD I^s-- CM ^■ t

LO CD CM rt rt LO CM LO rt LO ^■si- d LO CO

LO CN rt CD

^•st rt CM CM CM oq o I^s-; CD oq C-D co σ> co^" CM d LO I^s-^" I^s-^' CD I^s-- CO co σi co^" CM

00 LO CN 00 CM co CO "t o CM LO

CN 00 'st L0 C0 -- C0 <-D O -- CM 00 "st L0 C0 - - - -_t- -₅- t- τ- τ- CN CM CM CM CN CN CM

LO LO TABLE I (CONTINUED)

GROUP 1 AVERAGE BODY WEIGHT (a)

(CHICK

NUMBER and MALE DAY DAY DAY DAY DAY DAY or FEMALE) 6 7 14 21 28 35

1F 113.6 126.6 383.3 736.4 1300.4 1900 2F 142.2 157.7 457.4 506 1460.7. 2000 3F 137.3 160.4 461.5 889.2 1486.2 1950 4F 149.9 159.6 461.2 914.8 1472.9 2050 5F 133.4 152.3 454.1 902 1525 2050 6F 132.5 152.6 416.8 797.5 1248.8 1750 7F 120.9 137 405.9 799.6 1322.9 1850 8F 120.8 142.8 435.8 830.2 1408.2 2050 9F 135.6 153.7 422.5 852.7 1306 1950

LO LO TABLE I (CONTINUED)

GROUP 1 AVERAGE BODY WEIGHT (g)

(CHICK NUMBER and MALE DAY DAY DAY MORTALITY MORTALITY LESION r FEMALE 42 49 56 DAY CODE

1 M 2700 3450 3900 56 LB none

2M 2550 3400 4000 56 LB Yes

3M 2900 3650 3950 56 LB none

4M 40 DD Yes

5M 15 LB none

6M 2950 3400 3700 56 LB none

7M 2200 2700 3100 56 LB none

8M 3200 2650 2200 56 LB Yes

m OQ CD CD Q CD Q Q cD CD Q -Il Q DQ CQ ffi CD Q] _j _ι ---j ---j '-_ι --_ι Q Q -_ι _ι Q _ι Q _ι -_ι -_j _ι _j

CD CD CD CD CD CD CM σi CD CD CN

LO LO LO LO LO LO rt rt LO LO rt CO CM CD CN CD 00 CO

LO rt LO rt LO CM

O O O O LO O O LO o LO o LO o LO o LO o o LO o LO o LO CN CO CO O CO CD CD rt o LO I^s- CM oo CO CO CO CO co CN co 00 CN CN CO CM

CM C0 rt LO CD I^s- 00 O) o — CM 00 rt LO CD a CM CM CN CM CN CM CN

LO LO O CM

LO LO O CM

LO LO O CM TABLE I (CONTINUED)

GROUP 1 (CHICK

NUMBER DESCRIPTION OF ABNORMALITY IF ONE WAS PRESENT and MALE or FEMALE)

1M 2M 2+ E. acervulina-jejunum/duodenum 3M 4M hydropericardium (early ascites), swollen kidneys, mucus in trachea

5M 6M 7M 8M bacterial emboli liver/thoracic airsacculitis (cull bird) 9M

10M 2+ E. acervulina-jejunum/duodenum

11 M

12M

13M

14M 2-3+ E. acervulina-jejunum/duodenum

5 15M osteomyelitis in tibial head, broken femur

16M

17M tibial dyschondroplasia

18M 4+ E. acervulina-jejunum/duodenum

19M ϊ-α 10 20M femoral head necrosis/synovitis femoral head/liver hepatitis (mortality)

21 M 22M 23M 24M 15 25M thickened growth plates

26M

TABLE I (CONTINUED)

GROUP 1

(CHICK

NUMBER DESCRIPTION OF ABNORMALITY IF ONE WAS PRESENT and MALE or FEMALE)

1 F 2F

3F ascites/cirrhotic liver/hypotrophic heart (mortality)

4F 2+ E. acervulina-jejunum/duodenum

5F

6F femoral head necrosis

7F airsacculitis with pneumonia

8F moderate tracheitis (mucoid / trachea hemorrhagic)

9F tibial dyschondroplasia/osteomyelitis

10F ascites

U_ LL CM OO

LΩ LΩ O CM TABLE I (CONTINUED)

GROUP 2 AVERAGE BODY WEIGHT (o)

(CHICK NUMBER and MALE DAY DAY DAY DAY DAY DAY or FEMALE) 0 1 2 3 4 5 o 10

1 M 45.4 53.2 68 83.2 95.5 119.5 2M 48 60.6 76.2 96.6 116.2 120.9 3M 43.7 55.6 69 88.1 99.4 108

15 4M 46.8 54.8 67.6 84.8 101.8 104 5M 50 60.2 72.4 84 101.6 100.4 6M 46.1 58.8 71.5 89 106.9 116.9 7M 53.4 65.6 72.2 96.6 114 115.9 8M 43.9 54.4 67.2 82.6 97.6 105.8

20 9M 49.2 64.6 83.2 102 124.8 131.9

I^s- CO CM

00 CN

σ

m CO CN rt CM CM LO CM CO 00 rt rt 00 rt ---t CM CO

00 CD O 00 00 CO CN CN CO 00 CO CD CO σ> I^s- rt I^s- 00 I^s- 00 LΩ 00 oo 00 σi CD CD oo oo

rt 00 rt CM CM rt 00 V- CM CM CM oq rt CD 00 rt rt

I^s-- LΩ CD CD I^s-- 00 I-: I^s-: 00 C oi CD od CD d CO CO CD LΩ CO CD rt CD d I^s- CD i^ LO I^s- I^s- CO CD

rt CO oq LO rt CD I^s- ∞ rt CO CM rt OD CD rt CD

LΩ CN CD rt rt LΩ rt CM CD I-: CD CO rt LΩ LΩ CO I^s--- LΩ LΩ rt LΩ LΩ rt LΩ LΩ LO CD rt LΩ LΩ LO LΩ

CM CD rt CM CD oo CO rt 00 00 CO oq I^s-;

CM oo t 00 LΩ CM CO C3) CO rt rt rt r rt rt rt rt rt σi LΩ rt rt rt rt d CM

LΩ LΩ rt rt rt rt rt

CM 00 rt Ω CO l^s- C0 C3i O '-- CM C0 rt LD CD -- -- ^■5- CM CM CM CN CN CN CN

LΩ LΩ

LΩ LΩ O CM

LΩ LΩ

LΩ LΩ O CN 11 M 106.9 115.6 373.4 715.5 1284.8 1900

12M 122.7 137.1 363.5 819.3 1472.2 2250

13M 123.1 141 442.5 901.5 1532.4 2050

14M 132.8 146.4 431.3 864.7 1565.6 2100

15M 137.9 155.1 412.9 857.1 1532.5 2100

16M 130.2 149.9 431.1 809.7 1551.9 2150

17M 38.5

18M 88

19M 124.3 149.7 422.5 897.8 1464.2 2200

20M 110.1 126.5 369.8 636.9 1133.3 1950

21 M 135.1 151 454 875.2 1561.1 2250

22M 101 112.9 363.4 730.6 1283.9 1850

23M 145.1 168.4

24M 147.1 170.7 461.9 866.5

25M 134.4 156.6 489 1008.3 1697 2400

26M 128.3 144.1 438 911.9 1563.3 2150

TABLE I (CONTINUED)

GROUP 2 AVERAGE BODY WEIGHT (g)

(CHICK NUMBER and MALE DAY DAY DAY DAY DAY DAY or FEMALE) 6 7 14 21 28 35

1 F 127.1 142 384.4 710.9 1199.9 1650

2F 132.3 144.1

3F 151.6 175.6 444.5 935.8 1678.9 2400

4F 114.7 135 407.1 828.7 1397.5 1950

5F 134.6 147.9 412.8 554.5 1392.1 2000

6F 106.3 108.9 320.1 671 1151.4 1650

7F 146.4 157 481.6 968 1533.7 2050

8F 123.8 142.2 365.1 753 1262 1900

9F 125.2 140.1 400.2 763

LO LΩ TABLE I (CONTINUED)

GROUP 2 AVERAGE BODY WEIGHT (o)

(CHICK NUMBER and MALE DAY DAY DAY MORTALITY MORTALITY LESION or FEMALE) 42 49 56 DAY CODE

1 M 2600 3500 4000 56 LB Yes 2M 2750 2800 52 DD Yes 3M 15 LB none 4M 3050 42 LB Yes 5M 2350 3100 3700 56 LB Yes 6M 2900 3750 4100 56 LB none 7M 2950 3900 4400 56 LB Yes 8M 2650 3350 56 LB Yes 9M 2650 3250 3600 56 LB Yes

m cQ OQ m cQ CΩ Cθ O Q θQ --D --Ω CQ CΩ CQ CQ OΩ ---J -_J _l _l _J -_l ---j Q Q --_-l -_l _l _l ---J _l -_I ---J

CO CD CO CD CD CD CD I^s- LΩ LΩ LΩ LΩ LΩ LO LO LO S CO CD 00 00 CO

' ' W if) CM LO

CM 00 rt LΩ CΩ I^s- 00 CD O -- CM C0 rt LΩ C0 "- r- T- t- t- T- - x- CM CM CM CN CM CM CN

LΩ LΩ TABLE I (CONTINUED)

GROUP 2 AVERAGE BODY WEIGHT (o)

(CHICK

NUMBER and MALE DAY DAY DAY MORTALITY MORTALITY LESION or FEMALE) 42 49 56 DAY CODE

1 F 2000 2400 2600 56 LB Yes

2F 12 DD Yes

3F 2550 49 DD Yes

4F 2450 3000 3250 56 LB none

5F 2550 3000 3350 56 LB none

6F 2200 2750 3100 56 LB none

7F 2600 3200 3500 56 LB none

8F 2450 3050 49 DD none

9F 28 LB Yes

10F 2900 3600 3950 56 LB none

Ω LΩ TABLE I (CONTINUED)

GROUP 2 (CHICK NUMBER DESCRIPTION OF ABNORMALITY IF ONE WAS PRESENT and MALE or FEMALE)

1M 2+ E. acervulina-jejunum/fractured left femur 2M ascites 3M 4M airsacculitis 5M 3+ E. acervulina-jejunum/duodenum 6M 7M moderate tracheitis (mucoid/hemorrhagic) 8M 2+ E. acervulina-jejunum/duodenum 9M ascites (mild) hypotrophic heart/cirrhotic liver 10M

11M

12M

13M

14M 15M

16M

17M dead - omphalitis

18M dead - septicemia

19M hepatitis (mortality) 20M

21M

22M

23M

24M thickened growth plates 25M

26M

TABLE I (CONTINUED)

GROUP 2 (CHICK

NUMBER DESCRIPTION OF ABNORMALITY IF ONE WAS PRESENT and MALE or FEMALE)

1F 2+ E. acervulina-jejunum/duodenum 2F green from autolysis and had ascites 3F synovitis, broken leg, femoral head necrosis 4F 5F 6F 7F 8F 9F thickened growth plates, small retained yolk, enteritis 10F 11F

12F

13F

14F

15F 16F ascites/hypotrophic heart/cirrhotic liver

17F

18F

19F

20F 21 F synovitis

22F enteritis & mottled liver

23F

24F

25F 26F 2+ E. acervulina-jejunum/duodenum

TABLE I (CONTINUED)

GROUP 3 AVERAGE BODY WEIGHT (g)

(CHICK NUMBER and MALE DAY DAY DAY DAY DAY DAY or FEMALE) 0 1 2 3 4 5

1M 45.9 53.8 65.2 83.4 101.7 110.8

2M 50.4 61.2 82 99.2 122 137

3M 48 55.6 69.2 83.4 101.1 105.6

4M 52.2 59.2 70.6 84.2 101.1 104.2

5M 46.1 65.2 67.8 86 101.9 104.8

6M 51.2 59.6 68.8 87.4 104.1 106.5

7M 52.4 65.2 80.2 101 121.3 129.9

8M 52.4 59.8 72 90.2 104.8 117.1

9M 50 57.6 70.2 84.8 104.3 109.7

LO O LΩ TABLE I (CONTINUED)

GROUP 3 AVERAGE BODY WEIGHT (g)

(CHICK NUMBER and MALE DAY DAY DAY DAY DAY DAY or FEMALE) 0 1 2 3 4 5

1F 51.8 63.8 78.6 92.8 110.5 112.2

2F 46 61.2 74.4 90.6 108.3 115.7

3F 47.3 58.4 67.6 80 96.1 106.1

4F 48.1 58 73.6 89.2 102.9 106.1

5F 47.2 59.4 68 79.6 94.4 100.3

6F 47.5 61.2 73.2 90 107.5 118.7

7F 46.6 55.6 65.6 75.6 89.3 101.4

8F 42.7 56.6 68 78 93.9 97.5

LΩ CM rt 00 CO CD CD CD LΩ CD rt CN CO 00 CN v- o CD oo

I^s- CD CD rt CD CD - CN 00 d CM CO CD CM I^s--: 1^ CD O oo rt CD CM O δ

I^s- CD oo CD rt LΩ I^s- d CO CD LΩ CD LΩ CD CD

CM CM CD CD CD CO O O T— O LΩ I^s--: CM LΩ

O I^s- CD O O d 00 O O 00 CM CD o CD

rt 00 CM OO CD CN OO CD OO OO OO rt CM CN

CM 00 LΩ LO rt 00 oo o CD CD O CN CN CD CO 00 00 CD oo CD oo oo oo oo O 00

CD 00 rt CD

CD CD 00

co co oo oo CN rt CM 00 CO CD rt 00 CD

I^s- I^s- CO CD CD CN rt I^s--: CD O O CD 00 O LΩ LTD I^s- LO CD 00 I^s- LΩ CD I^s- I^s- CD LΩ 00 CD CD

00 00 CD OO rt rt CN I^s- CN rt 00 CO CM

CM LΩ O CD O CN CD CO LΩ O CN I^s- O I^s-

CD CD LΩ CD LΩ I^s- CD rt LΩ O CN LΩ CD CD LΩ LΩ CD LΩ CO CO LΩ

CN oo CM LΩ 00 LΩ OO CD CD T- 00 LΩ LΩ CD CO 00

CO rt CO I^s- CD CN -- LΩ rt CD od co CO CD CN v- I^s- O rt rt rt rt LΩ LΩ rt rt rt rt rt rt rt rt LΩ rt -Ω

LL LL LL LL LL LL LL LL LL LL LL LL LL LL LL

CD O -- CM 00 rt LO CO I^s- ∞ (Ji O CN 00 rt LΩ CO τ- τ- T- CM CN CN CN CN CN CN

LΩ LΩ O CN TABLE I (CONTINUED)

GROUP 3 AVERAGE BODY WEIGHT (g)

(CHICK NUMBER and MALE DAY DAY DAY DAY DAY DAY or FEMALE) 6 7 14 21 28 35

Ul

1M 128.6 151.9 427.61 847.4 1445.2 2050 2M 162.7 192.5 545.2 1081.8 1798.9 2400 3M 139.4 155.6 405.6 800 1395.6 2100

15 4M 139.7 156.2 400.1 960.8 1434.6 2050 5M 124.8 145.8 426.9 810 1423.4 2050 6M 132.6 156.1 396.3 818 1527.9 2250 7M 150.1 179.3 8M 143 154.5 425 877.8 1568 2250

20 9M 134.1 145.9 365 828.4 1430.8 2050

O o O O O O O O O O O O O O O LΩ LΩ O LΩ O LΩ LΩ O LO O O O rt CoO CO rt CM CN CN CN CN rt CN rt CM CM T— CM CN CN CN CN CN CM CN CM CM cvi

OO CO I^s- rt rt I^s- CN CD LΩ CO 00 rt CM 00

OO CD O rt 00 o CM I^s- LΩ I^s- -r- CD 00 00 CN O rt CD CO CD o CM CD 00 CM LΩ CD CD 00 CO 00 CD LΩ 00 CD LΩ CD LΩ LΩ CD LΩ LΩ rt rt

T— ^— ^'v~ ^{τ_ τ—} ^~ T- ^τ— T—

rt CD CD CN CM CD I^s- 00 oo CM CD LΩ CO o rt ,_

CD 00 CO LΩ I^s- CD O CD CD O LO oo CM I^s- oo

LΩ O O 00 CO CO I^s- LΩ OO CN CD LΩ 00 oo CD rt I^s- CD CD CD CD CD 00 CD CD 00 CD CD 00 oo

CD CD ,_ CO CD CM LΩ rt rt I^s- IΩ LΩ rt CD CM rt 00 LΩ

CD 00 CD co CN v- CN T— I^s- LΩ CM O r ⁰t L *"O rt r "<-t rt rt rt CO I^s- CN CD I^s- I^s- LΩ 00 rt I^s- rt rt rt rt rt rt rt rt rt rt

CM LΩ CO 00 oo CO 00 00 rt I^s- CD rt I^s- ,_

LO CM

LΩ O CD LΩ rt CO CN CN CM 03 O O CM O rt LΩ LΩ CD 00 00 LΩ rt I^s- LΩ LΩ rt CM LΩ LΩ CD CO co ^—

CD I^s- LΩ rt LΩ CD I^s-; rt oo CD I^s- CD 00 I^s- CD CD rt LΩ rt CD LΩ CD T— rt CM LΩ rt 00 rt co CD 00 CO

CM 00 CN rt 00 CO X— 00 CM rt CN

CM OO rt LΩ CD I^ OO CD O T- CN OO rt LΩ CD -- ^■r- -_!- -r- - - -- τ- CM CN CN CN CN CN CN

LΩ O LΩ

LΩ LΩ O CN

LO LO

LΩ LΩ O CM

^Q cQ ω CQ CQ OQ OQ OQ Q cQ OQ OQ Q cQ OQ CQ OQ Ω _ι _ι _j __ι _-i _ι _-ι Ω _ι _ι _ι O _ι .-_-ι _ι __]

CM CD CD -Ω OO LΩ CD CD CN CD CD CO O CN CD CD CD --Ω -Ω LΩ -t- CM OO LΩ LΩ rt LΩ LΩ LΩ LΩ rt LΩ LΩ LΩ

CM 00 rt LΩ CD I^s- 00 CD O - CM 00 rt --Ω C0 ^•c- T- T- - - T- - T- CM CM CN CN CN CN CN

LΩ O LΩ TABLE I (CONTINUED)

GROUP 3 AVERAGE BODY WEIGHT (o)

(CHICK

1 F 35 DD Yes

2F 2800 3150 3300 56 LB none

3F 2300 3000 3400 56 LB none

4F 2350 3000 3350 56 LB none

5F 1800 1850 1900 56 LB Yes

6F 2650 3200 3600 56 LB none

7F 2400 3000 3300 56 LB none

CQ CQ CQ OQ CQ Q CQ CQ CQ CQ CQ CQ CQ Q

OQ 9 O^Q CD CQ _l Q _! Q _l _l

CD CD CN OO CD t- CD CD CD CD CD CD LΩ LΩ LΩ rt CM LO LΩ LΩ LΩ LO LΩ LΩ i-

CM 00 CM CD 00 rt rt LO LΩ o o o Ω O LΩ LΩ O LΩ LO LΩ

CO LΩ 00 00 CN 00

CO 00 oo 00 CO CO CO OO 00 o O O

LΩ LΩ LΩ O CD rt 00 00 00 o O O o O O O O O

LΩ O LΩ o O LΩ O LΩ LΩ CM CD rt CO 00 CD O O

00 00 CN CO CM CM CN 00 CO O O O O O LΩ 00 O CM CM 00 00 o o O O O O o O O O

LΩ LΩ LΩ O LΩ LΩ LΩ O LΩ O

LΩ LΩ CO rt LΩ ^•τ— CM CM rt rt O O O O O

CM CN CN CM CM CN CM CM CN CN LΩ LΩ LΩ O LΩ CM LΩ LΩ CD LΩ CM CM CN CN CM

LL LL LL LL LL L LL LL LL LL LL LL U_ LL LL 00 CD ≤ CN CO rt LO CO 00 CD O t- CM 00 rt LΩ CO CN CM CN CN CM CN CN

LΩ LΩ O CM TABLE I (CONTINUED)

GROUP 3

5 (CHICK

NUMBER DESCRIPTION OF ABNORMALITY IF ONE WAS PRESENT and MALE or FEMALE)

10

1 M airsacculitis with pneumonia, tracheitis

2M (mortality)

3M

4M

15 5M 2+ E. acervulina-jejunum/duodenum

6M tibial dyschondroplasia

7M small retained yolk

8M

9M

20 10M

11 M

12M ascites (mild)/hypotrophic heart/mild cirrhosis

13M

14M thickened growth plates, enteritis 15M broken leg, reddened intestines & mottled liver

16M

17M 2+ E. acervulina-jejunum/duodenum

18M

19M 20M

21M

22M

23M proventriculitis

24M 25M

26M 2+ E. acervulina-jejunum/duodenum

TABLE I (CONTINUED)

GROUP 3

(CHICK

NUMBER DESCRIPTION OF ABNORMALITY IF ONE WAS PRESENT and MALE or FEMALE)

1 F liver was mottled

2F

3F

4F

5F ascites/cirrhotic liver/hypotropied heart (cull) 6F 7F 8F 9F

10F airsacculitis

11 F thickened growth plates, enteritis

12F

13F dead - omphalitis and septicemia

14F

15F 2+ E. acervulina-jejunum/duodenum

16F 17F 18F 19F 20F 21F 22F 23F 24F 25F 26F

As can be seen, the number of chicks that died early on their own

(denoted with DD) were:

Group 1 (high dose) 10 chicks DD

Group 2 (control) 8 chicks DD

Group 3 (low dose) 7 chicks DD and thus, there was no statistical difference in death for those who were given hydrolyzed GROGEL compared to those who received no GROGEL.

Accordingly, chicks were successfully hydrated with a composition of hydrolyzed SAP.

EXAMPLE II (treatment of chickens with SAP containing additive) A flock of 800 chicks and a flock of 1300 chicks at 2 respective hatcheries were placed in boxes with 100 chicks each. Then, 540 chicks (of the 800 chick flock) and 960 chicks (of the 1300 chick flock) were treated with a gel composition of hydrolyzed GROGEL admixed with PREEMPT. The

PREEMPT came from two different lots as designated below. All chicks in the flocks were either fresh or day old.

More specifically, for some of the boxes, all 100 chicks per box were maintained as controls and not treated. For some of the boxes, 20 chicks of the 100 chicks per box were separated out and were administered 0.25 ml of only PREEMPT (not the composition) by gavage for comparison. For the remainder of the boxes, all 100 chicks per box were administered the gel composition by being allowed to consume ad libitum either a 100 g sample per box or a 200 g sample per box. The 100 g samples contained 4 g of GROGEL, 75 ml of water, and 25 ml of PREEMPT. The 200 g samples contained 8 g of GROGEL, 175 ml of water, and 25 ml of PREEMPT. Thus, both the 100 g samples and the 200 g samples were 4% of SAP.

At 48 hours after placement of the chicks in the boxes, 210 cecal samples, comprising droppings, were collected and the chicks were destroyed.

From each of the 210 cecal samples, the VFA content (propionate, acetate, buyrate, or valerate) was determined. Everything went smooth during the course of this trial. All chicks appeared to consume the gel composition very well. The temperature in the 800 chick hatchery was 68°-72°F (20°-22.2°C) in the chick room (where gel treatment occurred). The temperature in the 1300 chick hatchery was also 68°- 72°F (20°-22.2°C) in the chick room. The area where the chicks were pulled was cooler in the 1300 chick hatchery (about 60°F, 15.6°C) than in the 800 chick hatchery (about 72°F, 22.2°C).

Gel treated chicks were stacked during exposure. Therefore, the top box was exposed to a light intensity of about 70 foot candles while the lower boxes were exposed to a light intensity of less than 1 foot candle. Chicks consumed the gel composition very well even in the darker boxes.

The treatment of the chicks is summarized in Table II A below.

TABLE II A

(540 treated chicks)

Gel

Box Exposure Composition PREEMPT

Number GEL Time Chick Consumed LOT

(g) (min) Age (g) NUMBER

1 100 60 Fresh 76 1

2 100 120 _. Fresh ^"90 1

3 200 60 Fresh 125 1

4 200 120 Fresh 145 1

5 100 120 Fresh 90 2

6* gavage NA Fresh NA 1

7* gavage NA Fresh NA 2

8** none NA Fresh none none

TABLE II A (CONTINUED)

(960 treated chicks)

Gel

Box Exposure Composition PREEMPT

Number GEL Time Chick Consumed LOT

(g) (min) Age (g) NUMBER

1 100 60 Fresh 71 2 100 120 Fresh 96 3 200 60 Fresh 121 4 200 120 Fresh 144 5 100 60 Day Old 90 6 100 120 Day Old 93 7 200 60 Day Old 135 8 200 120 Day Old 188

9 100 120 Fresh 93 2

10* gavage NA Fresh NA 1

11* gavage NA Day Old NA 1

12* gavage NA Fresh NA 2

13** none NA Fresh none none

*Of the 100, only 20 were separated out and thus were gavage treated chicks, which were comparisons (only PREEMPT, n SAP). **These chicks were controls (no PREEMPT, no SAP).

Rather than attempting to use the mean as a measure of effectiveness of administration, compared were th percentage of birds within various categories that yielded cecal propionate levels greater than 7 μmol/g and greater than 4 μmol/g. It has been shown previously that chicks yielding greater than 7 μmol propionate per gram of cecal droppings hav been optimally administered with PREEMPT and that the culture is properly established, and it is generally agreed that chick yielding greater than 4 μmol propionate per gram of cecal droppings have probably been adequately administered with PREEMPT. Therefore, chicks with levels of propionate greater than 7 μmol/g are in great shape and those with levels greate than 4 μmol/g are probably in good shape relative to PREEMPT administration.

The following Table II B summarizes the percentages of chicks at the 4 μmol and the 7 μmol levels of propionate pe gram of cecal droppings. Chicks are grouped by age of chick, grams of gel composition to which chicks were exposed, minute

of exposure to the gel composition, and Lot of PREEMPT (i.e., Lot 1 or Lot 2). All percentages are based on 39 to 40 chick per group except for the Lot groups, where only 10 chicks were used in each group.

TABLE II B

(540 treated chicks)

% OF CHICKS YIELDING PROPIONATE

-4 10 GROUP OF CHICKS > 4 μmol/g > 7 μmol/g

(all fresh)

100 g Gel Composition 0 0

200 g Gel Composition 0 0

15

60 Minutes Exposure 0 0

120 Minutes Exposure 0 0

>T 1 PREEMPT 0 0

20 ⁾T 1 Gavage 20 10

TABLE II B (CONTINUED)

(960 treated chicks)

% OF CHICKS YIELDING PROPIONATE

GROUP OF CHICKS > 4 μmol/g > 7 μmol/g Day Old 45 30

Fresh 30 20

00 g Gel Composition 45 25 00 g Gel Composition 35 25

60 Minutes Exposure 50 35 20 Minutes Exposure 30 20

1 PREEMPT 20 10 2 PREEMPT 70* 60*

1 Gavage Day Old 90 90 1 Gavage Fresh 90 90

LOT 2 Gavage Fresh 100 100

laboratory technician(s) not following proper protocol is believed to be the cause of a higher % of chicks for thos chicks that received PREEMPT from LOT 2 as compared to LOT 1.

Also, each of the 210 cecal samples collected was analyzed for contents of each kind of VFA (acetate, propionate butyrate, and valerate). The results are summarized in μmole of VFA per g of cecal dropping sample as per Table II C below except sample 82 is not reported due to a preparation error by the laboratory technician(s).

TABLE II C

10

15

LΩ LΩ

LΩ LΩ -4

10

15

LΩ -Ω

LΩ LΩ

LΩ LΩ

LΩ LΩ

LΩ LΩ -4 oe

10

15

-4

10

15

LΩ LΩ

LΩ LΩ oe

10

Thus, a composition of PREEMPT admixed with GROGEL was shown to be effective for hydration of chicks t administer PREEMPT to them.

As an addendum, 2 boxes of gel treated chicks were re-exposed to gel composition (one box exposed to "regular" ge composition and one box to gel composition colored with green food coloring). Each of these boxes contained 80 chicks. Eac

15 box received 200 g gel and was exposed for 45 minutes at approximately 70 foot candles light intensity. The chicks expose to the "regular" gel consumed 112 g gel composition while the chicks exposed to the green gel consumed 156 g ge

composition. The chicks in these 2 boxes had been exposed to gel composition for 60 minutes just prior to this addendum experiment. Although it appears the chicks preferred the gel composition to be colored green, this preference was not demonstrated in substantially similar tests where consumption of green composition was compared with consumption of regular composition.

EXAMPLE 111 (treatment of chickens with

SAP containing additive) A similar experiment was repeated as in Example II, but this time all compositions of GROGEL, PREEMPT, and water also contained green food coloring dye. Also similarly, a control group of chicks was not given any gel composition.

More particularly, chicks were treated with a gel composition of hydrolyzed GROGEL admixed with PREEMPT and food coloring. They were placed in 12 boxes with 100 chicks each, and then housed in 2 separate pens with 50 chicks each. They were administered 0.25 ml of only PREEMPT (not the composition) by gavage for comparison or were administered the gel composition by being allowed to consume ad libitum either a 100 g sample per box or a 200 g sample per box.

The 100 g samples contained 4 g or 8 g of GROGEL, 75 ml of water, and 25 ml of PREEMPT. The 200 g samples contained 8 g or 16 g of

GROGEL, 175 ml of water, and 25 ml of PREEMPT. Thus, some of the 100 g samples were 4% of SAP and some were 8% of SAP. Also, some of the 200 g samples were 4% of SAP and some were 8% of SAP.

At 48 hours after placement of the chicks in the boxes, 15 chicks from each group of 100 chicks were destroyed, and ceca removed. From the ceca, the amount of propionate was determined. The results are summarized in Table III A below. TABLE III A

Average

Exposure Gel Green Dye Amount of

Box GEL Time SAP Consumed (liquid or Propionate Number (g) (min) % (g) powder) μmol/g

oe

Ul 10 1 100 60 4 71 liquid 4.28

2 100 120 4 96 liquid 7.54

3 200 60 4 121 liquid 14.83

4 200 120 4 144 . liquid 6.55

5 100 60 8 90 liquid 5.84

15 6 100 120 8 93 liquid 3.86

7 200 60 8 135 liquid 3.71

8 200 120 8 188 liquid 4.41

9* 100 (15g) 120 8 93 liquid 5.16

10**gavage (1g) NA 8 NA liquid 9.58

20 11**gavage (1g) NA 8 NA powder 14.64

12**^* none NA NA none none 1.88

*The gel composition also contained 15 g of nutrition prepared by Milk Specialties, Inc. **Gavage treated chicks treated with PREEMPT + SAP. ***These chicks were controls (no PREEMPT, no SAP).

For the treated birds, all cecal propionate levels were close to or greater than 4 μmol/g.

Thus, a composition of PREEMPT admixed with hydrolyzed GROGEL was shown to be effective for hydration of chick to administer PREEMPT to them.

Also, each of the collected 15 ceca samples per box (for all 12 boxes) was analyzed for content of each kind of VF (acetate, propionate, butyrate, and valerate). The results are summarized in μmole of VFA per g of ceca sample as per Tabl III B below.

TABLE III B

oe

-4

10

15

LΩ

10

o o

10

As can be seen from contrasting the results from chicks that were treated (boxes 1 through 11 ) with the results from chicks that were not treated (box 12), a composition of PREEMPT admixed with hydrolyzed GROGEL was shown to be effective for hydration of chicks to administer PREEMPT to them.

It will be understood that various details of the invention may be changed without departing from the scope of the invention. Furthermore, the foregoing description is for the purpose of illustration only, and not for the purpose of limitation-the invention being defined by the claims.

Claims

CLAIMS What is claimed is:

1. A method of treating dehydration in a warm-blooded vertebrate animal comprising administering to said animal a treatment effective amount of a superabsorbent polymer.

2. The method of claim 1 , wherein administering a treatment effective amount of a superabsorbent polymer comprises administering a superabsorbent polymer selected from the group consisting of acrylate polymers; alkali metal acrylate copolymers; propenenitrile homopolymers, alkali metal salts; polymers of propenaminde and propenoic acid, alkali metal salts; acrylonitrile copolymers; starch graft copolymers and terpoiymers thereof; and combinations thereof.

3. The method of claim 2, wherein the superabsorbent polymer is in admixture with an additive agent to form a superabsorbent polymer composition.

4. The method of claim 3, wherein the additive agent is selected from the group consisting of an excipient, a nutriment, a carrier, a surfactant, a medicament, a growth enhancer, a microbial control agent, a prebiotic, a probiotic, a competitive exclusion culture, and combinations thereof.

5. The method of claim 1 , wherein the dehydration has a cause selected from the group consisting of pathogens, nutritional factors, environmental factors, physiological disorders, and combinations thereof.

6. The method of claim 5, wherein the environmental factors are selected from the group consisting of heat, chilling, shipment of animals, air pollution toxins, water pollution toxins, and combinations thereof.

7. The method of claim 5, wherein the pathogens are selected from the group consisting of parasites, bacteria, protozoa, and viruses, food toxins, and combinations thereof.

8. The method of claim 1 , wherein administering a superabsorbent polymer to the vertebrate animal comprises administering a superabsorbent polymer to a vertebrate animal selected from the group consisting of birds and mammals.

9. The method of claim 8, wherein the birds are fowl.

10. The method of claim 9, wherein the fowl are selected from the group consisting of turkeys, chickens, ducks, geese, and guinea fowl.

11. The method of claim 8, wherein the mammals are selected from the group consisting of humans, ruminants, carnivores, horses, and swine.

12. The method of claim 1 , wherein administering a treatment effective amount of a superabsorbent polymer comprises administering a superabsorbent polymer in bolus form, tablet form, particulate form, and combinations thereof.

13. The method of claim 12, wherein administering comprises administering a superabsorbent polymer in a human food form, an animal feed form, and combinations thereof.

14. The method of claim 1 , wherein administering a superabsorbent polymer comprises administering a treatment effective amount of a superabsorbent polymer administered to the vertebrate animal in a range from about 0.05 gram to about 2.0 gram per kilogram of body weight of the vertebrate animal.

15. The method of claim 1 , wherein administering a treatment effective amount of a superabsorbent polymer comprises further including water.

16. The method of claim 15, wherein the superabsorbent polymer is hydrolyzed by the water prior to administration.

17. A dehydration treatment composition for a warm-blooded vertebrate animal, the composition comprising a superabsorbent polymer in admixture with an additive agent.

18. The composition of claim 17, wherein the superabsorbent polymer is selected from the group consisting of acrylate polymers; alkali metal acrylate copolymers; propenenitrile homopolymers, alkali metal salts; polymers of propenaminde and propenoic acid, alkali metal salts; acrylonitrile copolymers; starch graft copolymers and terpoiymers thereof; and combinations thereof.

19. The composition of claim 17, wherein the additive agent is selected from the group consisting of an excipient, a nutriment, a carrier, a surfactant, a medicament, a growth enhancer, a microbial control agent, a prebiotic, a probiotic, a competitive exclusion culture, and combinations thereof.

20. The composition of claim 17, wherein the vertebrate animal is selected from the group consisting of birds and mammals.

21. The composition of claim 20, wherein the birds are fowl.

22. The composition of claim 21 , wherein the fowl are selected from the group consisting of turkeys, chickens, ducks, geese, and guinea fowl.

23. The composition of claim 20, wherein the mammals are selected from the group consisting of humans, ruminants, carnivores, horses, and swine.

24. The composition of claim 17, wherein the composition is in bolus form, tablet form, particulate form, and combinations thereof.

25. The composition of claim 24, wherein the composition is in a human food form, an animal feed form, and combinations thereof.

26. The composition of claim 17, wherein the composition is a treatment effective amount in a range from about 0.05 gram to about 2.0 gram of superabsorbent polymer per kilogram of body weight of the vertebrate animal.

27. The composition of claim 17, wherein the composition further comprises water.

28. The composition of claim 27, wherein the superabsorbent polymer is hydrolyzed by the water.