WO2001043570A1 - Composition permettant d'ameliorer la reponse proliferative durant l'adaptation du tractus gastro-intestinal et utilisation dans le cadre du syndrome de l'intestin court - Google Patents

Composition permettant d'ameliorer la reponse proliferative durant l'adaptation du tractus gastro-intestinal et utilisation dans le cadre du syndrome de l'intestin court Download PDF

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Publication number
WO2001043570A1
WO2001043570A1 PCT/US2000/033783 US0033783W WO0143570A1 WO 2001043570 A1 WO2001043570 A1 WO 2001043570A1 US 0033783 W US0033783 W US 0033783W WO 0143570 A1 WO0143570 A1 WO 0143570A1
Authority
WO
WIPO (PCT)
Prior art keywords
acid
arachidonic acid
beverage
docosahexaenoic acid
nutritionally complete
Prior art date
Application number
PCT/US2000/033783
Other languages
English (en)
Inventor
Jon Arvid Vanderhoof
Kathryn Anne Kollman
Eric Louis Lien
John Charles Wallingford
Original Assignee
Wyeth
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to EP00984311A priority Critical patent/EP1237424A1/fr
Application filed by Wyeth filed Critical Wyeth
Priority to CA002391259A priority patent/CA2391259A1/fr
Priority to PL00356781A priority patent/PL356781A1/xx
Priority to BR0016469-0A priority patent/BR0016469A/pt
Priority to IL14980500A priority patent/IL149805A0/xx
Priority to NZ519932A priority patent/NZ519932A/en
Priority to MXPA02005940A priority patent/MXPA02005940A/es
Priority to HU0203654A priority patent/HUP0203654A3/hu
Priority to EA200200687A priority patent/EA200200687A1/ru
Priority to AU20951/01A priority patent/AU2095101A/en
Priority to JP2001544517A priority patent/JP2003516946A/ja
Publication of WO2001043570A1 publication Critical patent/WO2001043570A1/fr
Priority to NO20022865A priority patent/NO20022865L/no

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12—Fatty acids or derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention is directed to methods of treating patients with short bowel syndrome and to formulations containing long chain polyunsaturated fatty acids (PUFA's) useful in such methods.
  • PUFA's long chain polyunsaturated fatty acids
  • Short bowel syndrome is the term used to describe the state of nutrient malabsorption following extensive surgical resection of small intestine (Vanderhoof, J. A., Gastroenterology 113(5): 1767-78 (1997)).
  • the extent to which malabsorption occurs depends not only on the quantitative amount of absorptive tissue removed from the small intestine, but also in the particular portion of the small intestine that is removed. For example, removal of the distal portion of the ileum can result in a more adverse result than removed of the proximal bowel, because removal of the ileocecal valve allows freer communication between the remaining small intestine and the large intestine.
  • the prohferative response is also influenced by the provision of luminal nutrition.
  • Fat digestion and absorption is especially problematic when short bowel syndrome occurs in infancy, as fat digestive capability is developmentally limited in early life (e.g., Heineman, E. D. et al., Journal of Pediatric Surgery 31(4):520-5 (1996)).
  • the use of medium chain triglycerides has been suggested as a means to bypass the need to package fat into triglyceride in the intestinal epithelial cell and ease the stress on fat absorption (Goulet, O., European Journal of Medical Research 2(2):79-83 (1997)).
  • the provision of essential fatty acids to the patient with short bowel syndrome is an important nutritional objective.
  • One treatment group had 0% of arachidonic acid and docosahexaenoic acid; one had 5% arachidonic acid and 3.3% docosahexaenoic acid; another group had 15% arachidonic acid and 10% docosahexaenoic acid, and a fourth group had 45% arachidonic acid and 30% docosahexaenoic acid.
  • each animal has 80% or the bowel removed.
  • two of the diets no arachidonic acid or docosahexaenoic acid but high safflower oil and 45% arachidonic acid, 30% docosahexaenoic acid
  • the extent of resection was studied.
  • the extent of resection was 60%, 70% or 80%.
  • the very high arachidonic acid/docosahexaenoic acid level resulted in less proliferation in of remaining duodenum DNA than was seen when no arachidonic acid/docosahexaenoic acid were fed.
  • Measures of mucosal mass, protein and sucrase activity did not vary in the duodenum.
  • the high arachidonic acid/docosahexaenoic acid diet resulted in significantly greater mucosal mass and protein in the ileum than the diet with no arachidonic acid/docosahexaenoic acid.
  • the present invention is directed to methods for the treatment of short bowel syndrome in patients in need thereof comprising administering to the patient an effective amount of a formulation comprising arachidonic acid and docosahexanoic acid.
  • the invention is further directed to formulations suitable for use in such methods.
  • the present invention is directed to methods of treating short bowel syndrome by administrating to a patent with short bowel syndrome a formulation comprising arachidonic acid and docosahexanoic acid.
  • the amount of arachidonic acid may be at least equal to or greater than the amount of docosahexanoic acid.
  • the amount of arachidonic acid to docosahexanoic acid ranges from 2:1 to 1:1, and more preferably is in the ratio of 1.5:1.
  • the beverages of the invention preferably contain docosahexanoic acid in a quantity by weight of at least 1.5%, more preferably at least 2.2%, and advantageously at least 3.32%, calculated on the total fatty acid content of the beverage.
  • the quantity is advantageously 12%, calculated on the total fatty acid content of the beverage.
  • the beverages of the invention preferably contain arachidonic acid in a quantity by weight of at least 1.5%, more preferably at least 3.32%, and advantageously at least 4.44%, calculated on the total fatty acid content of the beverage.
  • the quantity is advantageously 18%, calculated on the total fatty acid content of the beverage.
  • the present formulations have been found to be particularly useful in the treatment of short bowel syndrome.
  • the ratios of arachidonic acid to docosahexanoic acid set forth above also apply.
  • the present invention is not limited to a particular formulation, as long as the appropriate amounts of arachidonic acid and docosahexanoic acid are contained therein.
  • the present formulation is a complete nutritional beverage comprised of protein, carbohydrate, vitamins and minerals, and containing a specific blend of vegetable fats suitable to achieve a special fatty acid pattern.
  • the formulations of the present invention may be formulated in a liquid form or as a powder intended to be reconstituted in suitable amounts of water prior to consumption.
  • the invention is formulated in a manner that it is capable of providing the complete nutritional needs of an infant with short bowel syndrome. Both infancy and short bowel syndrome independently place rigorous dietary requirements on the individual, and hitherto, as noted above, there has been no adequate nutritional intervention that simultaneously meets the needs of both infancy and short bowel syndrome.
  • the fatty acids useful in the present formulations may be preferably produced in the form of single cell oils.
  • the level of docosahexaenoic acid in the present formula may be equal to or greater than the level of docosahexaenoic acid that has been affirmed by the U. S. Food and Drug Administration as generally recognized as safe for the general population (a total intake of 3 g/day). (21 CFR 184. XX).
  • the intended use of the present formula is in the treatment of short bowel syndrome, the limitations relevant for the general food supply are not relevant as a safety concern.
  • a preferred embodiment of the present invention is a nutritionally complete infant formula suitable for use in the present method to treat short bowel syndrome in infants and children.
  • Such formulas comprise proteins, carbohydrates, lipids and effective amounts of arachidonic acid and docosahexaenoic acid according to the present invention.
  • infant formula When diluted or reconstituted, if initially in concentrated or powder form, to the ready to feed state, a typical infant formula will comprise about 60-110 grams of carbohydrates per liter, 10-35 grams of protein per liter, and 20-50 grams of lipid per liter, as well as vitamins, minerals, fibers, emulsifiers, etc. To such an infant formula one can add appropriate amounts of arachidonic acid and docosahexaenoic acid in accordance with the present invention. Examples of suitable commercially available infant formulas to which the arachidonic acid and docosahexaenoic acid may be added include the S-26, S-26LBW and SMA infant formulas available from Wyeth Nutritionals International Inc.
  • the formulas useful in the present invention do not contain lactose as a carbohydrate, as is typically the case in standard infant formulas, but rather contain maltodextrin.
  • Maltodextrin may be used in conjunction with an alternate form of polymeric glucose, including starches, that have previously been used in infant formula, e.g. tapioca starch.
  • a portion of the carbohydrate, as much as 20%, may be in the form of sucrose to improve the taste of the formulation.
  • This use of carbohydrates allow the formula to be consumed orally for a longer duration of time following resection.
  • amount of carbohydrate in order to avoid the excess metabolic production of D-lactic acid contained in the final formulation must be carefully considered by intestinal bacteria.
  • the caloric distribution of the formula A is approximately 28.4% CHO; 16.8% protein, and 54.8% fat; 150 kcal/lOOcc.
  • Various fat blends that may be used to optimize the provision of the high amounts of arachidonic acid and docosahexaenoic acid necessary in the present formulations are shown below.
  • Fat Blends 1-3 contain varying concentrations of arachidonic acid and docosahexaenoic acid in formulas that would comply with FDA's GRAS affirmation on docosahexaenoic acid consumption. These particular fat blends could be best employed in management of short bowel syndrome following the period of rapid proliferation, in order to maintain individuals on high arachidonic acid/docosahexaenoic acid diets.
  • This concentration of docosahexaenoic acid+arachidonic acid, in a ratio of 1 : 1 will provide 3.0 g/d LCPs at 1666 kcal/d.
  • DHASCO O 50% docosahexaenoic acid
  • ARASCO 50% arachidonic acid
  • This level of DHASCO and ARASCO will provide 3.0 g/d LCP at 750 kcal/d, but in a 2:1 ratio of arachidonic acid to docosahexaenoic acid.
  • the preferred formulation for short bowel syndrome uses larger amounts of arachidonic acid and docosahexaenoic acid than this.
  • the level of arachidonic acid is 18% of the fatty acids
  • the level of docosahexaenoic acid is 12% of fatty acids (Table 7).
  • Fat Blend #4 vegetable 10% hydrogenated coconut oil 15% DHASCO (40% docosahexaenoic acid) 30% ARASCO (40% arachidonic acid) 45% 100
  • the co implete fatty acid composition of Fat Blend #4 is set forth below: Fatty acid distribution on preferred fat blend
  • Arachidonic acid metabolism may be investigated by the use of pharmacologic agents that selectively block routes of arachidonic acid metabolism by inhibition of cyclooxygenase and hpoxygenase.
  • the prohferative response of the duodenum was increased by treatment with an inhibitor of hpoxygenase.
  • a study completed by the present inventors involving the dietary management of a series of children with short bowel syndrome found that a high fat, low carbohydrate, high calorie enteral diet allowed more rapid weaning from total parenteral nutrition, i.e. faster attainment of full enteral feeds, and less occurrence of bacterial overgrowth. Included in the study group were children who previously had difficulty tolerating standard enteral feeds comprised of amino acid or hydrolyzed protein formulas, and who demonstrated improved weight gain after changing to the high fat formula.
  • arachidonic acid rich diets of this invention are quantitatively superior to any previous dietary treatment for short bowel syndrome.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Polymers & Plastics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Mycology (AREA)
  • Nutrition Science (AREA)
  • Food Science & Technology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pediatric Medicine (AREA)
  • Epidemiology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne des techniques de traitement du syndrome de l'intestin court chez des patients qui en sont atteints. Ces techniques consistent à administrer à ces patients une quantité efficace d'une préparation comprenant de l'acide arachidonique et de l'acide docasahexanoïque.
PCT/US2000/033783 1999-12-17 2000-12-14 Composition permettant d'ameliorer la reponse proliferative durant l'adaptation du tractus gastro-intestinal et utilisation dans le cadre du syndrome de l'intestin court WO2001043570A1 (fr)

Priority Applications (12)

Application Number Priority Date Filing Date Title
NZ519932A NZ519932A (en) 1999-12-17 2000-12-14 Formulations comprising arachidonic acid (AA) and docosahexanoic acid (DHA) in nutritionally complete beverages
CA002391259A CA2391259A1 (fr) 1999-12-17 2000-12-14 Composition permettant d'ameliorer la reponse proliferative durant l'adaptation du tractus gastro-intestinal et utilisation dans le cadre du syndrome de l'intestin court
PL00356781A PL356781A1 (en) 1999-12-17 2000-12-14 Composition for improving the proliferative response during adaptation of the gastrointestinal tract and use in short bowel syndrome
BR0016469-0A BR0016469A (pt) 1999-12-17 2000-12-14 Composição para melhorar a resposta proliferativa durante a adaptação do trato gastrointestinal e uso na sìndrome do intestino delgado
IL14980500A IL149805A0 (en) 1999-12-17 2000-12-14 Composition for improving the proliferative response during adaptation of the gastrointestinal tract and use in short bowel syndrome
EP00984311A EP1237424A1 (fr) 1999-12-17 2000-12-14 Composition permettant d'ameliorer la reponse proliferative durant l'adaptation du tractus gastro-intestinal et utilisation dans le cadre du syndrome de l'intestin court
MXPA02005940A MXPA02005940A (es) 1999-12-17 2000-12-14 Composicion para mejorar la respuesta proliferativa durante la adaptacion del tracto gastrointestinal y el uso en el sindrome de intestino corto.
AU20951/01A AU2095101A (en) 1999-12-17 2000-12-14 Composition for improving the proliferative response during adaptation of the gastrointestinal tract and use in short bowel syndrome
EA200200687A EA200200687A1 (ru) 1999-12-17 2000-12-14 Композиция для усиления пролиферативного ответа в процессе адаптации желудочно-кишечного тракта и применения при синдроме укороченной тонкой кишки
HU0203654A HUP0203654A3 (en) 1999-12-17 2000-12-14 Composition for improving the proliferative response during adaptation of the gastrointestinal tract and use in short bowel syndrome
JP2001544517A JP2003516946A (ja) 1999-12-17 2000-12-14 消化管の適応の間における増殖応答を向上させる組成物および短腸症候群における使用
NO20022865A NO20022865L (no) 1999-12-17 2002-06-14 Blanding for forbedring av proliferativ respons under tilpassing av mage-tarmkanalen og anvendelse i "kort tarm" syndrom

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US46675199A 1999-12-17 1999-12-17
US09/466,751 1999-12-17

Publications (1)

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WO2001043570A1 true WO2001043570A1 (fr) 2001-06-21

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PCT/US2000/033783 WO2001043570A1 (fr) 1999-12-17 2000-12-14 Composition permettant d'ameliorer la reponse proliferative durant l'adaptation du tractus gastro-intestinal et utilisation dans le cadre du syndrome de l'intestin court

Country Status (18)

Country Link
EP (1) EP1237424A1 (fr)
JP (1) JP2003516946A (fr)
KR (1) KR20030016211A (fr)
CN (1) CN1411347A (fr)
AR (1) AR026988A1 (fr)
AU (1) AU2095101A (fr)
BR (1) BR0016469A (fr)
CA (1) CA2391259A1 (fr)
CZ (1) CZ20021960A3 (fr)
EA (1) EA200200687A1 (fr)
HU (1) HUP0203654A3 (fr)
IL (1) IL149805A0 (fr)
MX (1) MXPA02005940A (fr)
NO (1) NO20022865L (fr)
NZ (1) NZ519932A (fr)
PL (1) PL356781A1 (fr)
WO (1) WO2001043570A1 (fr)
ZA (1) ZA200205673B (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003009818A (ja) * 2001-07-03 2003-01-14 Morinaga Milk Ind Co Ltd 乳児用栄養組成物
US8877812B2 (en) 2010-12-29 2014-11-04 Abbott Laboratories Methods for decreasing the incidence of necrotizing enterocolitis, colic, and short bowel syndrome in an infant, toddler, or child

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2420210C2 (ru) * 2006-03-23 2011-06-10 Нестек С.А. Высококалорийная питательная добавка

Citations (4)

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Publication number Priority date Publication date Assignee Title
WO1997026804A1 (fr) * 1996-01-26 1997-07-31 Abbott Laboratories Formule ou supplement nutritionnel pour alimentation enterale contenant des acides arachidonique et docosahexanoique
WO1997035487A1 (fr) * 1996-03-26 1997-10-02 Gist-Brocades B.V. Particules porteuses solides revetues de pufa pour produits alimentaires
JPH09285267A (ja) * 1996-04-24 1997-11-04 Meiji Milk Prod Co Ltd ｎ−６系列／ｎ−３系列脂肪酸バランス 改善ヌクレオチド含有乳児用食品
US5709888A (en) * 1990-10-30 1998-01-20 Abbott Laboratories High fat nutritional formula for infants and adults

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5709888A (en) * 1990-10-30 1998-01-20 Abbott Laboratories High fat nutritional formula for infants and adults
WO1997026804A1 (fr) * 1996-01-26 1997-07-31 Abbott Laboratories Formule ou supplement nutritionnel pour alimentation enterale contenant des acides arachidonique et docosahexanoique
WO1997035487A1 (fr) * 1996-03-26 1997-10-02 Gist-Brocades B.V. Particules porteuses solides revetues de pufa pour produits alimentaires
JPH09285267A (ja) * 1996-04-24 1997-11-04 Meiji Milk Prod Co Ltd ｎ−６系列／ｎ−３系列脂肪酸バランス 改善ヌクレオチド含有乳児用食品

Non-Patent Citations (2)

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Title
KOLLMAN KATHRYN A ET AL: "Dietary lipids influence intestinal adaptation after massive bowel resection.", JPGN, vol. 28, no. 1, January 1999 (1999-01-01), pages 41 - 45, XP000992379 *
PATENT ABSTRACTS OF JAPAN vol. 1998, no. 03 27 February 1998 (1998-02-27) *

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003009818A (ja) * 2001-07-03 2003-01-14 Morinaga Milk Ind Co Ltd 乳児用栄養組成物
JP4694053B2 (ja) * 2001-07-03 2011-06-01 森永乳業株式会社 乳児用栄養組成物
US8877812B2 (en) 2010-12-29 2014-11-04 Abbott Laboratories Methods for decreasing the incidence of necrotizing enterocolitis, colic, and short bowel syndrome in an infant, toddler, or child
US9078847B2 (en) 2010-12-29 2015-07-14 Abbott Laboratories Nutritional products including a novel fat system including monoglycerides
US9078846B2 (en) 2010-12-29 2015-07-14 Abbott Laboratories Nutritional products including monoglycerides and fatty acids
US9433586B2 (en) 2010-12-29 2016-09-06 Abbott Laboratories Methods of improving tolerance related to feeding in an infant, toddler, or child
US9844517B2 (en) 2010-12-29 2017-12-19 Abbott Laboratories Nutritional products including a novel fat system including fatty acids

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Publication number Publication date
NO20022865D0 (no) 2002-06-14
AR026988A1 (es) 2003-03-05
CN1411347A (zh) 2003-04-16
IL149805A0 (en) 2002-11-10
EP1237424A1 (fr) 2002-09-11
CZ20021960A3 (cs) 2003-03-12
MXPA02005940A (es) 2003-10-14
KR20030016211A (ko) 2003-02-26
HUP0203654A3 (en) 2003-10-28
NZ519932A (en) 2004-02-27
NO20022865L (no) 2002-06-14
AU2095101A (en) 2001-06-25
PL356781A1 (en) 2004-07-12
JP2003516946A (ja) 2003-05-20
BR0016469A (pt) 2002-08-27
ZA200205673B (en) 2004-02-23
CA2391259A1 (fr) 2001-06-21
HUP0203654A2 (hu) 2003-04-28
EA200200687A1 (ru) 2003-02-27

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