WO2007076534A1 - Method for modifying gut flora in animals - Google Patents
Method for modifying gut flora in animals Download PDFInfo
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- WO2007076534A1 WO2007076534A1 PCT/US2006/062702 US2006062702W WO2007076534A1 WO 2007076534 A1 WO2007076534 A1 WO 2007076534A1 US 2006062702 W US2006062702 W US 2006062702W WO 2007076534 A1 WO2007076534 A1 WO 2007076534A1
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- 239000011723 β-tocotrienol Substances 0.000 description 1
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Definitions
- the present invention relates to methods for modifying the bacterial flora of the gastrointestinal tract (gut), and in some cases reducing gastrointestinal inflammation, in animals, more particularly animals having inflammatory bowel disease (IBD) or at risk for IBD.
- the methods involve dietary intervention; accordingly the invention further relates to food compositions useful in practicing such methods.
- the invention still further relates to kits and communicating means useful in practicing the invention.
- the enhancement attributable to the method is associated with reduction of inflammation.
- the method further comprises administering to the animal at least one of a probiotic and a prebiotic.
- the invention also provides use of at least one antioxidant in the preparation of a composition for enhancing the balance of beneficial and deleterious bacteria in the gastrointestinal tract of an animal having or at risk for IBD.
- a food composition comprising, on a dry matter basis, at least one of: a. vitamin E in an amount of about 50 to about 1000 ⁇ g/g: b. vitamin C in an amount of about 30 to about 400 ⁇ g/g; and c. ⁇ -carotene in an amount of about 0.1 to about 5 ⁇ g/g: and further comprising at least one of a probiotic and a prebiotic.
- a kit comprising ( I ) a composition comprising at least one antioxidant, and (2) at least one of: a. a probiotic: b. a prebiotic: c. a base food; d. an anti-lBD agent: and e. instructions for administering the antioxidant-containing composition and optionally other components of the kit to an animal having or at risk for IBD. to enhance the balance of beneficial and deleterious bacteria in the gastrointestinal tract.
- the means comprises one or more of a document, a digital storage medium, an optical storage medium, an audio presentation and a visual display containing the information and/or instructions.
- a method of the invention is for enhancing the balance of beneficial and deleterious bacteria in the gastrointestinal tract of an animal having or at risk for IBD.
- the method comprises administering to the animal a composition comprising at least one antioxidant.
- the gut flora i.e.. the community of bacteria resident in the gastrointestinal tract, comprises both beneficial and deleterious bacterial types or species. Whether a particular member of the gut flora is beneficial, deleterious or inconsequential to the health of the animal in particular circumstances can depend on a number of factors, but lor the purposes of the present invention certain types or species of bacteria can be considered beneficial and others deleterious.
- beneficial members of the gut flora include bifidobacteria (species of the genus Bifidobacterium) and lactic acid bacteria, more particularly species of the genus Lactobacillus. Deleterious bacteria include pathogenic bacteria.
- Examples of deleterious members of the gut flora include Clostridium spp.. Desulfovibrio spp. (including without limitation D. desulfuricans. D. intestinalis and D. vulgaris). Helicobacter spp. (including without limitation H. bizzozeronii, H. felis. H. heilmannii. H. pylori and H. salomonis) and pathogenic forms of Escherichia coli.
- Gastrointestinal health typically depends on maintenance of an appropriate balance of beneficial and deleterious bacteria.
- An increase in the population of deleterious bacteria and/or a decrease in the population of beneficial bacteria can be associated with a decline in gastrointestinal health.
- an increase in the population of beneficial bacteria and/or a decrease in the population of deleterious bacteria can be associated with an improvement in gastrointestinal health, for example restoration of health or remission in an animal having a gastrointestinal disorder such as IBD, or prevention of onset of disease in an animal at risk for such a disorder.
- the term "'associated with” in the present context does not necessarily imply a causal relationship, thus the balance of beneficial and deleterious bacteria can be implicated in pathogenesis or can be merely symptomatic of a gastrointestinal disorder.
- “Enhancing” or “enhancement” of the balance herein means shifting the balance in favor of beneficial bacteria, and thus can involve an increase in beneficial bacteria and/or a decrease in deleterious bacteria.
- enhancement of the balance arises from both a reduction in deleterious, e.g.. pathogenic, bacteria and an increase in beneficial bacteria.
- Bacterial populations in the gut flora can be estimated by any procedure known in the art.
- stool samples can be cultured using traditional plating methodologies, or illustratively by the fluorescence in situ hybridization (FISH) technique.
- FISH fluorescence in situ hybridization
- the subject animal according to the present method is one "having or at risk for IBD/ '
- An animal having IBD is an animal in which any one of a spectrum of inflammatory gastrointestinal diseases and disorders recognized as a form of IBD has been professionally diagnosed or an animal exhibiting symptoms consistent with such diagnosis.
- diseases and disorders include without limitation irritable bowel syndrome (IBS), ulcerative colitis and Crohn ' s disease.
- An animal having chronic IBD but in remission at the time of application of the method is considered herein to be an animal '"having IBD.”
- An animal at risk for IBD is an animal not having a history of IBD or exhibiting IBD symptoms but having one or more risk factors indicating a susceptibility to development of IBD.
- risk factors can include genetic factors (e.g., a family history of IBD) and physiological factors (e.g.. elevated levels of one or more pro-inflammatory biomarkers and/or depressed levels of one or more anti-inflammatory biomarkers).
- the animal can be human or non-human, including avian, bovine, canine, equine, feline, hircine. murine, ovine and porcine animals.
- the animal is a companion animal such as a canine or feline, particularly a dog or a cat.
- a composition comprising at least one antioxidant is administered to the animal. Administration can be by any suitable route, including oral or parenteral, but is typically oral.
- the composition is a food that is orally administered. Such a food comprising at least one antioxidant can represent a substantial part of the diet of an animal.
- At least one antioxidant can be present in a food or range of foods consumed daily by the animal and providing substantially complete nutrition of the animal.
- at least one antioxidant can be administered as a nutritional supplement, or can be present in a snack, a treat or an at least partially edible toy given to the animal separately from its regular food.
- Any nutritionally acceptable antioxidant can be used.
- an antioxidant other than one having pharmacological properties as in the case of drugs such as 5-ASA or prodrugs thereof
- an antioxidant other than a polyphenol is used, although a polyphenol antioxidant such as taxifolin can optionally be present in addition to a non-polyphenol antioxidant.
- a variety of materials that exhibit free radical quenching or absorbing capacity can be used as antioxidants (for example, fruits, vegetables, certain vitamins, and other chemical compounds).
- Raw ingredients with high oxygen radical absorbing content include, for example, raw spinach pomace, raw tomato pomace, raw citrus pulp, raw grape pomace, raw carrot granules, raw broccoli, raw green tea, raw corn gluten meal, and raw rice bran.
- Foods or food products that exhibit free radical quenching or absorbing capacity include, for example, spinach (e.g., spinach pomace), tomato (e.g.. tomato pomace), citrus fruit (e.g.. citrus pulp), grape (e.g., grape pomace), carrot (e.g.. carrot granules), broccoli, corn gluten meal, and rice bran.
- Compounds that exhibit free radical quenching or absorbing capacity include, for example, vitamin ⁇ . vitamin C, carotenoids. coenzyme Qio (ubiquinone), glutathione, L-carnitine, ⁇ -lipoic acid, N-acetylcysteine, S-adenosylmethionine, soy isoflavones and taurine.
- the composition to be administered comprises one or more of vitamin E. vitamin C and a carotenoid.
- vitamin E herein includes any form of vitamin E suitable for consumption by an animal including, but not limited to, any tocopherol or tocotrienol compound, any enantiomer or racemate thereof, and any mixture of such compounds having vitamin E activity. e.g.. ⁇ -tocopherol (5.7,8-trimethyltocoI), ⁇ -tocopherol (5,8-dimethyltocol). ⁇ -tocopherol (7.8-dimethyltocol). ⁇ -tocopherol (8-methyltocol). ⁇ -tocotrienol (5.7,8-trimethyltocotrienol). ⁇ -tocotrienol (5.8-dimethyltocotrienol).
- Vitamin E can be administered as any one or a mixture of the above compounds or in the form of various derivatives thereof such as esters, including vitamin E acetate, succinate, palmitate and the like, that exhibit vitamin E activity after ingestion by an animal.
- vitamin E as used in the present method comprises ⁇ -tocopherol or an ester thereof.
- Vitamin E amounts can be expressed in international units (IU) wherein 1 IU is an amount of vitamin E having vitamin E activity equivalent to 1 mg DL- ⁇ -tocopheryl acetate. Alternatively, vitamin E amounts can be expressed as total tocopherol.
- vitamin C herein includes any form of vitamin C suitable for consumption by an animal including, but not limited to. ascorbic acid, L-ascorbic acid, and various derivatives thereof such as calcium phosphate salt, cholesteryl salt, and ascorbate-2- monophosphate.
- Salts of vitamin C include the sodium salt, calcium salt, zinc salt, and ferrous salt.
- Esters include stearate, palmitate and like derivatives.
- Vitamin C can be in any physical form such as a liquid, a semisolid, a solid, or a heat stable form that exhibits vitamin C activity after ingestion by a patient. Vitamin C amounts are expressed herein as ascorbic acid.
- the term '"carotenoid” herein includes any form of a carotenoid suitable for consumption by an animal including, but not limited to, natural and synthetic carotenoids derived from orange -yellow pigment in plants, algae, leaves, roots, vegetation, tomato meal, red palm oil. tomato powder, and tomato pomace/pulp.
- the carotenoid ⁇ -carotene is a precursor of vitamin A occurring naturally in plants.
- the antioxidant activity of carotenoids is generally independent of any vitamin A activity they may possess as a result of metabolism to vitamin A by an animal. In this regard, it is noted that cats in particular are generally unable to convert ⁇ -carotene to vitamin A.
- Other carotenoids include astaxanthine. ⁇ -carotene, cryptoxanthin, lutein, Iycopene and zeaxanthin.
- Suitable amounts of one or more antioxidants for administration herein can be expressed in relation to the amount of food (typically expressed on a dry matter basis) consumed by the animal.
- the antioxidant-containing composition can be administered in an amount providing one or more of: a. vitamin E in a total tocopherol amount of about 50 to about 1000 ⁇ g. for example about 100 to about 800 ⁇ g, or about 200 to about 600 ⁇ g; b. vitamin C in an amount of about 30 to about 400 ⁇ g, for example about 50 to about 200 ⁇ g. or about 75 to about 150 ⁇ g: and c. carotenoid. e.g.. ⁇ -carotene. in an amount of about 0.1 to about 5 ⁇ g. for example about 0.2 to about 2 ⁇ g, or about 0.5 to about 1.5 ⁇ g: per gram of food, on a dry matter basis, consumed.
- the composition to be administered according to the present method is a food forming a substantial part of an animal ' s diet
- the food should typically comprise, on a dry matter basis, one or more of: a. vitamin E in a total tocopherol amount of about 50 Io about 1000 ⁇ g/g, for example about 100 to about 800 ⁇ g/g. or about 200 to about 600 ⁇ g/g; b. vitamin C in an amount of about 30 to about 400 ⁇ g/g. for example about 50 to about 200 ⁇ g/g. or about 75 to about 150 ⁇ g/g; and c. carotenoid. e.g., ⁇ -carotcne, in an amount of about 0.1 to about 5 ⁇ g/g. for example about 0.2 to about 2 ⁇ g/g. or about 0.5 to about 1 .5 ⁇ g/g.
- all three of vitamin E, vitamin C and carotenoid e.g., ⁇ -carotene are present, illustratively in amounts as indicated above.
- compositions comprising vitamin E, vitamin C and/or a carotenoid are other than a food forming a substantial part of the animal's diet, it should typically be administered in an amount consistent with that set forth above, in relation to the amount of food consumed by the animal.
- a supplement a snack, a treat or an at least partially edible toy.
- the composition contains higher concentrations of antioxidant(s) than set forth above, as the total amount of such compositions consumed is substantially lower than in the case of a food forming a substantial part of the diet.
- vitamin E enriched in vitamin E.
- ⁇ -carotene can enhance the balance of beneficial and deleterious bacteria in an animal's gut flora by comparison ⁇ vith a comparative food having lower levels of these antioxidants.
- the enhancement involves both an increase in the population of beneficial bacteria and a decrease in the population of deleterious bacteria.
- the enhancement of gut flora balance attributable to practice of the method is associated with reduction of inflammation, more particularly reduction of gastrointestinal inflammation, such as inflammation of the colonic mucosa.
- Reduction of inflammation may be directly observable, for example by colonoscopy, or may be evidenced by a decrease in one or more pro-inflammatory biomarkers and/or an increase in one or more anti-inflammatory biomarkers in a biofluid or tissue of the animal.
- pro-inflammatory biomarkers that may be decreased in blood serum include C-reactive protein (CRP). oxidized glutathione (GSSG). alkenals, serum amyloid A (SAA) and tumor necrosis factor alpha (TNF- ⁇ .
- cytokine a pro-inflammatory cytokine
- anti-inflammatory biomarkers include reduced glutathione (GSH). oxygen radical absorbing capacity (ORAC), and the anti-inflammatory cytokines transforming growth factor beta (TGF- ⁇ ) and interleukin 10 (IL-IO).
- GSH glutathione
- ORAC oxygen radical absorbing capacity
- TGF- ⁇ transforming growth factor beta
- IL-IO interleukin 10
- a method of the invention comprises, in addition to administration of a composition comprising an antioxidant, administration of one or more of a probiotic and a prebiotic.
- a probiotic is a preparation or composition comprising viable microbes, for example bacteria, molds or yeasts.
- Probiotics of interest herein comprise at least one kind of beneficial bacteria, for example bifidobacteria and/or lactic acid bacteria.
- a probiotic useful herein comprises beneficial bacteria comprising one or more of Bifidobacterium spp. and Lactobacillus spp.
- Suitable species include, without limitation. Bifidobacterium animalis (including B. animalis subsp. lactis. sometimes referred to as B. lactis).
- Bifidobacterium thermophilum Lactobacillus acidophilus. Lactobacillus animalis, Lactobacillus casei, Lactobacillus plantarum. Lactobacillus reuteri. and Lactobacillus rhamnosus.
- a probiotic can be included in the same composition as the antioxidant, for example in a food composition, or it can be administered separately.
- a suitable amount of a probiotic is generally about 10 6 to about IO 12 cfu (colony forming units) per gram of food on a dry matter basis consumed by the animal.
- a probiotic can enhance the balance of the gut flora simply by acting as an inoculum for an increased population of beneficial bacteria, and/or by antagonizing growth of deleterious bacteria. In some situations co-action of the antioxidant and a probiotic can occur, and this may under some circumstances lead to a synergistic interaction of the antioxidant and the probiotic. although such synergism is not a requirement herein.
- a prebiotic is a nondigestible substance that preferentially stimulates growth of beneficial bacteria.
- Most prebiotics are fermentable carbohydrates; examples include oligosaccharides, galactans and ⁇ -glucans. obtainable from various plant and microbial sources. Specific examples include arabinogalactan. fructooligosaccharide (FOS) and inulin. a polysaccharide that yields FOS.
- the prebiotic can be administered separately from or in the same composition, e.g., a food composition, as the antioxidant.
- a method of the invention comprises administering an anti-lBD agent, in addition to a composition comprising an antioxidant, and optionally a probiotic and/or a prebiotic.
- An "anti-IBD agent” herein is a pharmacological agent, typically a drug or herbal preparation, providing therapeutic benefit to an IBD patient, for example in reducing inflammation, alleviating symptoms such as pain and/or diarrhea, etc. Suitable examples include, without limitation, steroids such as beclomethasone, budesonide. prednisolone, prednisone and tixocortol; 5-ASA releasing preparations such as mesalamine.
- the anti-IBD agent can be administered by any suitable route, including oral, parenteral, transdermal and rectal routes. If desired, an anti-IBD agent suitable for oral administration can be included in the same composition as the antioxidant.
- an aspect of the invention is use of at least one antioxidant in preparation of a composition for enhancing the balance of beneficial and deleterious bacteria in the gastrointestinal tract of an animal having or at risk for IBD. All embodiments described or enumerated above for a method of the invention apply equally to such use.
- the invention provides, in yet another embodiment, a food composition, useful for example in practice of a method as described herein.
- a food composition of the present embodiment typically has a content of metabolizable energy and nutrients that render it suitable as a substantial part of the diet of an animal.
- the composition comprises, on a dry matter basis. ( 1 ) at least one of: a. vitamin E in a total tocopherol amount of about 50 to about 1000 ⁇ g/g.
- vitamin C in an amount of about 30 to about 400 ⁇ g/g, for example about 50 to about 200 ⁇ g/g, or about 75 to about 150 ⁇ g/g: and c. carotenoid. e.g., ⁇ -carotene. in an amount of about 0.1 to about 5 ⁇ g/g. for example about 0.2 to about 2 ⁇ g/g, or about 0.5 to about 1.5 ⁇ g/g; and (2) at least one of a probiotic and a prebiotic.
- the composition comprises a probiotic comprising beneficial bacteria of one or more of Bifidobacterium spp. and Lactobacillus spp.
- a suitable amount of probiotic is typically about 10 f) to about 10 12 cfu/g. on a dry matter basis.
- the composition comprises a prebiotic comprising one or more of an oligosaccharide, a galactan or a ⁇ -glucan.
- the food composition generally contains amounts and a balance of nutrients appropriate to the animal for which it is intended.
- the composition is a pet food, for example a food nutritionally and/or organoleptically adapted for feeding to a companion animal such as a canine or feline.
- a kit of the invention comprises (I) a composition comprising at least one antioxidant, and (2) at least one of: a. a probiotic; b. a prebiotic; c. a base food; d. an anti-lBD agent: and e. instructions for administering the antioxidant-containing composition and optionally other components of the kit to an animal having or at risk for IBD, to enhance the balance of beneficial and deleterious bacteria in the gastrointestinal tract.
- kits can be co-packaged, for example provided in separate containers within a single outer package or otherwise bundled together.
- components of the kit can be separately packaged but made available (e.g.. sold, offered for sale or marketed) in such a way that a consumer can obtain all necessary components. This can be accomplished by means, for example, of "virtual packaging' * , wherein instructions in a medium separate from physical components of the kit relate to use of the physical kit components.
- the medium for the instructions can be. but are not limited to, print, radio or television broadcast, website or visual display, for example at a point of sale.
- the kit comprises a base food, a composition comprising at least one antioxidant, and one or more of a probiotic and a prebiotic.
- the base food contains amounts and a balance of nutrients appropriate to the animal for which it is intended but contains a low level of antioxidants, generally insufficient to provide enhancement of the balance of beneficial and deleterious bacteria in the gastrointestinal tract.
- the antioxidant- containing composition acts as a supplement, for addition to or admixture with the base food, to provide an antioxidant enriched food capable of providing the desired enhancement.
- a probiotic and/or a prebiotic, if included in the kit can be present in the supplement, or in the base food, or in a separate container.
- the kit of this embodiment optionally further comprises instructions for addition or admixture of the supplement to the base food and/or information about the benefits of such addition or admixture.
- the means comprises one or more of a document, a digital storage medium, an optical storage medium, an audio presentation and a visual display containing the information and/or instructions.
- the means can comprise a displayed web site, a brochure, a product label, a package insert, an advertisement or a visual display.
- a study is conducted with 1 1 healthy (not having IBD) cats and 1 1 cats diagnosed with IBD.
- a standard canned feline pet food with or without antioxidant enrichment (see analysis in Table I) is fed to the cats for 2 weeks, followed by crossover to the other food, which is fed for a further 2 weeks.
- Example 1 A study is conducted with 1 1 healthy cats and 1 1 cats diagnosed with IBD. Each of the same control (non-enriched) and test (antioxidant-enriched) foods as in Example 1 is fed to the cats for 4 weeks, followed by crossover to the other food, which is fed for a further 4 weeks. Stool (fecal) samples are collected at the beginning and end of each 4-week feeding period and are submitted for bacterial culture using traditional plating methodology. Counts for two kinds of deleterious bacteria (Clostridia and E. coli) and two kinds of beneficial bacteria (lactic acid bacteria and bifidobacteria) are obtained. Results are shown in Table 4.
- E. coli population is about 3 log units (about one thousand times) higher in samples from cats with IBD than in samples from healthy cats.
- Cats fed the antioxidant-enriched food exhibit a decline of about 0.8 to about 1 log unit in E. coli population by comparison with the control food.
- the antioxidant-enriched food also tend to lower Clostridium populations, although this effect is more marked in healthy cats than in cats with IBD.
- populations of beneficial bacteria both lactic acid bacteria and bifidobacteria
- an antioxidant-enriched diet to animals with IBD can enhance the balance of beneficial and deleterious bacteria in the gut flora.
- Such enhancement can be further assisted, for example by supplementing an antioxidant-enriched food with one or more probiotics comprising beneficial bacteria such as Lactobacillus spp. or Bifidobacterium spp.
Abstract
Description
Claims
Priority Applications (10)
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AU2006330421A AU2006330421B2 (en) | 2005-12-29 | 2006-12-29 | Method for modifying gut flora in animals |
EP06846849.5A EP1978821B2 (en) | 2005-12-29 | 2006-12-29 | Method for modifying gut flora in animals |
JP2008548864A JP2009522311A (en) | 2005-12-29 | 2006-12-29 | Methods for regulating intestinal flora in animals |
CA002635038A CA2635038A1 (en) | 2005-12-29 | 2006-12-29 | Method for modifying gut flora in animals |
ES06846849T ES2379824T3 (en) | 2005-12-29 | 2006-12-29 | Method to modify the intestinal flora in animals |
AT06846849T ATE541469T1 (en) | 2005-12-29 | 2006-12-29 | METHOD FOR MODIFYING THE INTESTINAL FLORA IN ANIMALS |
DK06846849.5T DK1978821T3 (en) | 2005-12-29 | 2006-12-29 | Method of Modifying Intestinal Flora in Animals |
BRPI0620734-0A BRPI0620734A2 (en) | 2005-12-29 | 2006-12-29 | method for improving the balance of beneficial and harmful bacteria in an animal's gastrointestinal tract, use of at least one antioxidant, feed composition, kit, and means for communicating information and / or instructions |
CN200680049706.0A CN101351124B (en) | 2005-12-29 | 2006-12-29 | Method for modifying gut flora in animals |
ZA2008/05413A ZA200805413B (en) | 2005-12-29 | 2008-06-20 | Method for modifying gut flora in animals |
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EP (1) | EP1978821B2 (en) |
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DK (1) | DK1978821T3 (en) |
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ZA (1) | ZA200805413B (en) |
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WO2011070010A1 (en) * | 2009-12-11 | 2011-06-16 | Technische Universität Graz | Prebiotic |
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Also Published As
Publication number | Publication date |
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RU2426451C2 (en) | 2011-08-20 |
CN101351124A (en) | 2009-01-21 |
AU2006330421A1 (en) | 2007-07-05 |
RU2008131072A (en) | 2010-02-10 |
AU2006330421B2 (en) | 2011-03-24 |
US20070178078A1 (en) | 2007-08-02 |
ZA200805413B (en) | 2013-03-27 |
EP1978821B1 (en) | 2012-01-18 |
BRPI0620734A2 (en) | 2012-09-18 |
ATE541469T1 (en) | 2012-02-15 |
CN101351124B (en) | 2014-09-03 |
CA2635038A1 (en) | 2007-07-05 |
DK1978821T3 (en) | 2012-05-14 |
EP1978821B2 (en) | 2019-02-06 |
JP2009522311A (en) | 2009-06-11 |
EP1978821A1 (en) | 2008-10-15 |
ES2379824T3 (en) | 2012-05-04 |
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