Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Bacteria or actinomycetales
Patent
1997-12-12
1999-12-28
Witz, Jean C.
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Bacteria or actinomycetales
424 933, 424 9345, 424 9348, 514561, C12N 120
Patent
active
060078081
DESCRIPTION:
BRIEF SUMMARY
The present invention refers to pharmaceutical and dietary formulations for the prophylaxis and treatment of gastrointestinal disorders.
BACKGROUND OF THE INVENTION
Gastrointestinal disorders, including viral, bacterial and protozoal infections, as well as chronic inflammatory diseases, or radiation damages, exert a stress on gastrointestinal cells. The main nutrient of mucosal cells of the gastrointestinal tract is glutamine. This amino acid, usually non-essential, becomes "conditionally essential" in pathologies characterized by a glutamine requirement that exceeds the individual's ability to produce sufficient amount of this amino acid. Enteral or parenteral administration of glutamine improves nutritional management and recovery of the patients (Castel L M et al. (1994) Amino Acids 7, 231-243; Lacey J M, Wilmore D W (1990) Nutr. Rev. 48 (8), 297-309). Glutamine, apart from being the preferred fuel for cells with a rapid proliferation rate such as enterocytes and lymphocytes, is also a regulator for acid-base balance through the production of ammonia. Enterocytes are the most important cells of small intestine which use glutamine as an energy source (Wu G et al. (1995) Am. J. Physiol. 266, R334-R342; Nagy L E, Kretchmer N (1988) J. Nutr. 118 (2), 189-193). As a matter of fact, intestinal cells absorb a remarkable amount of glutamine supplied with the diet and whenever the supply of this amino acid is decreased, the amino acid is taken up from the blood. Low levels of glutamine, experimentally induced in animals, for instance through glutaminase administration, cause intestinal disorders, e.g. chronic diarrhoea, villous atrophy, etc., (Castel L M et al. (1994) Amino Acids 7, 231-243) thus confirming the importance of glutamine for the intestine. In conclusion, glutamine can be insufficient in certain disorders of the gastrointestinal tract. In such situations of glutamine deficiency, the gastrointestinal cells are more vulnerable and therefore more exposed to injury caused, for instance, by infectious agents or ionizing radiations. Conversely injury and stress to gastrointestinal cells can augment their energetic needs, and thus their requirement of glutamine for survival or replacement. Consequently glutamine administration can augment the ability of gastrointestinal cells to withstand injury. In addition, the above mentioned positive effects on gastrointestinal cells due to glutamine administration can be further enhanced by the addition of arginine which acts both on the immune system and the wound-healing rate (Wu G et al. (1995) Am. J. Physiol. 266, R334-R342). Carbohydrates are thought to act in synergy with glutamine, but alone they cannot substitute it (Wu G et al. (1995) Am. J. Physiol. 266, R334-R342).
In solution glutamine is not completely stable. In particular, during heat sterilization of glutamine solutions, pyroglutamate and glutamic acid may form. Glutamine containing polypeptides are much more stable. Upon ingestion of such polypeptides, glutamine may be released in the stomach and intestine by proteases. Therefore a sufficient amount of glutamine can be also achieved by administering small or large polypeptides containing glutamine such as for instance L-alanyl-L-glutamine or glycyl-L-glutamine or glycyl-glycyl-L-glutamine.
Lactic acid bacteria, particularly lactobacilli, as well as other bacteria isolated from the gastrointestinal tract of healthy human beings or animals, have long been known to produce a prophylactic and therapeutic effect on gastrointestinal infections (Zoppi G. et al.(1982) Eur. J. Pediatrics 139, 18-21). Such bacteria go under the name of eubiotic bacteria. Some bacterial species may compete with pathogenic ones for nutrients and/or attachment sites on the gastrointestinal mucous membrane. In addition they can favor the return of pH to normal values. For instance, the strain Enterococcus faecium SF 68 (earlier called Streptococcus faecium SF 68), originally isolated from pig intestines, has been proven to be effective in clinical studies (Borgia M et al. (1982)
REFERENCES:
patent: 5397803 (1995-03-01), Smith et al.
patent: 5738651 (1998-04-01), Walton et al.
Bengmark, S. et al., "Gastrointestinal Surface Protection and Mucosa Reconditioning", Journal of Parenteral and Enteral Nutrition, vol. 19, No. 5, 1995, pp. 410-415.
Helwig, H. et al., "Helwig/Otto Arzneimittel", Ein Handbuch fur Arzte und Apotheker, Oct. 1988, pp. 38-92.
Lewenstein, A. et al., "Biological Properties of SF 68, A New Approach . . . ", Current Therapeutic Research, Clinical and Experimental, vol. 26, No. 6, Section 2, Dec. 1979, pp. 967-981.
De Haen Christoph
Gozzini Luigia
Dibra S.p.A.
Witz Jean C.
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