Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2000-10-23
2003-10-07
Kemmerer, Elizabeth (Department: 1647)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S012200, C424S184100, C424S198100, C424S085100, C530S350000, C530S399000
Reexamination Certificate
active
06630444
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates broadly to enhancing the functions of the small intestine and the treatment of inflammatory bowel diseases in a patient by the administration of leptin.
BACKGROUND OF THE INVENTION
Short bowel syndrome (“SBS”) is a devastating clinical disorder resulting from massive small bowel resection. SBS affects many infants and children and threatens normal growth and development. The remnant intestine naturally adapts to resection, however, this adaptation process is often inadequate to meet the patients fluid and nutritional goals. There is no effective treatment and current management includes total parenteral nutrition (“TPN”), which itself is a source of significant morbidity and mortality. Accordingly, there is a need for an alternative method of management for short bowel syndrome. Other disorders of the small intestine can render the bowel nonfunctional for a prolonged period of time such as severe infection and inflammatory bowel disease.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an alternative method for management for short bowel syndrome and other disorders of the intestine.
Accordingly, the present invention includes a method for treating a patient comprising the step of administering leptin to a subject having a condition resulting from inadequate intestinal function. Leptin may be administered in an amount ranging from about 1 &mgr;g/kg body weight/day to about 50 &mgr;g/kg body weight/day. In another embodiment leptin may be administered in an amount ranging from about 2 &mgr;g/kg body weight/day to about 20 &mgr;g/kg body weight/day. The patient may have a condition selected from the group consisting of short bowel syndrome, inflammation of the bowel, inflammatory bowel disease (such as, chronic ulcerative colitis and Crohn's Disease), necrotizing enterocolitis, intestinal atresia, midgut volvulus, severe acute gastroenteritis, chronic gastroenteritis, cholera, chronic infections of the bowel, and immunologic disorders affecting the small intestine.
In accordance with one embodiment of the present invention leptin may be administered systemically. In another embodiment leptin may be administered lumenally.
Further, leptin may be administered with nutritional supplements or with growth factors that increase the function of the intestine. In a preferred embodiment, the growth factors may be selected from the group consisting of HGF, EGF, IGF-1, IL-11, and GLP-2.
The present invention includes a method for supplying nutrients to a subject comprising the steps of providing nutrients to the subject and administering leptin to the subject in an amount effective to increase the absorption of the nutrients in the intestine of the subject. Leptin may be administered in an amount ranging from about 1 &mgr;g/kg body weight/day to about 50 &mgr;g/kg body weight/day. In another embodiment, leptin may be administered in an amount ranging from about 2 &mgr;g/kg body weight/day to about 20 &mgr;g/kg body weight/day. The subject may have a condition selected from the group consisting of short bowel syndrome, inflammation of the bowel, inflammatory bowel disease (such as, chronic ulcerative colitis and Crohn's Disease), necrotizing enterocolitis, intestinal atresia, midgut volvulus, severe acute gastroenteritis, chronic gastroenteritis, cholera, chronic infections of the bowel, and immunologic disorders affecting the small intestine. Leptin may be administered systemically or luminally.
Still further, the present invention includes a method for treating the intestine in a subject comprising the step of administering leptin to the subject in an amount effective to increase the intestinal function of the intestine. Still further, the method includes an amount of leptin that is effective to increase sugar absorption. The method may include an amount of leptin that is effective to increase amino acid absorption. Further, the method may include an amount of leptin that is effective to increase mucosal mass of the intestine. The amount of leptin ranges from 1 &mgr;g/kg body weight/day to about 50 &mgr;g/kg body weight/day. In another embodiment, leptin may be administered in an amount ranging from about 2 &mgr;g/kg body weight/day to about 20 &mgr;g/kg body weight/day. The subject may have a condition selected from the group consisting of short bowel syndrome, inflammation of the bowel, inflammatory bowel disease (such as, chronic ulcerative colitis and Crohn's Disease), necrotizing enterocolitis, intestinal atresia, midgut volvulus, severe acute gastroenteritis, chronic gastroenteritis, cholera, chronic infections of the bowel, and immunologic disorders affecting the small intestine. The leptin may be administered systemically or lumenally.
Leptin may be administered with nutritional supplements or with growth factors that increase the function of the intestine. In a preferred embodiment, the growth factors may be selected from the group consisting of HGF, EGF, IGF-1, IL-11, and GLP-2.
The method also includes increasing intestinal function beyond the function of the normal intestine. The method also includes increasing intestinal function beyond the normal adaptive response.
REFERENCES:
Ulshen et al. Luminal epidermal growth factor preserves mucosal mass of small bowel in fasting rats. Clin Sci 90: 427-431, 1996.*
Alavi et al. Leptin: a new growth factor for the small intestine. J Pediatric Surg 37(3): 327-330, 2002.*
Hill et al. Leptin: its pharmacokinetics and tissue distribution. Int J Obesity 22: 765-770, 1998.*
Ceddia et al. Leptin increases glucose transport and utilization in skeletal muscle in vitro. Gen Pharmac 31(5): 799-801, 1998.*
Fruhbeck et al. Relation between leptin and the regulation of glucose metabolism. Diabetlologia 43: 3-12, 2000.*
Lostao et al. Presence of leptin receptors in rat small intestine and leptin effect on sugar absorption. FEBS Letters 423: 302-306, 1998.*
Maffei et al. Leptin levels in human and rodent: measurement of plasma leptin and ob RNA in obese and weight-reduced subjects. Nat Med 1(11): 1155-1161, 1995.*
Molina et al. Serum leptin concentrations in patients with short-bowel syndrome. Clin Nutrit 19(5): 333-338, 2000.*
Morton et al. Leptin action in intestinal cells. J Biol Chem 273(40): 26194-26201, 1998.*
Pearson et al. Novel effect of leptin on small intestinal absorptive capacity after massive small bowel resection. J Surgical Res 93(2): P54, 2000.*
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O'Connor Darlise
Schwartz Marshall
Bunner Bridget E.
Kemmerer Elizabeth
McGuireWoods LLP
The Nemours Foundation
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