Mechanisms of Adaptation in Human Short Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2013-07-31

Brief Summary

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This is an observational, natural history trial of mechanisms of gut adaptation in adult short bowel syndrome (SBS). Patients with SBS (\< 200 cm small bowel ± colon) will be studied initially 2-9 months after the last small bowel resection and again exactly 6 months after the initial study. GCRC-studies will examine intestinal nutrient absorption, gut barrier functions and gut mucosal biopsy specimens for markers of nutrient transport and cell proliferation and apoptosis.

Detailed Description

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Short bowel syndrome (SBS) is a condition that occurs after massive surgical removal of sections of the small bowel required to treat conditions such as Crohn's disease, lack of adequate blood flow to the intestine, trauma, twisting of the bowel and other disorders. Patients with SBS develop severe diarrhea, weight loss, loss of nutrients in the stool, malnutrition, dehydration and deficiency of specific nutrients. SBS is thus a major cause of intestinal failure in adults and children. SBS has a high rate of death and medical complications and patients experience enormous health care-related costs and decreased quality of life. Patients with SBS often require intravenous feeding \[known as parenteral nutrition (PN)\] due to chronic malabsorption and malnutrition and also commonly develop infections from intestinal bacteria, suggesting abnormalities in the intestinal "barrier" to bacteria present in the intestine. In animal models of SBS, increased growth of the intestinal lining (mucosa) and improved nutrient absorption occur over time (intestinal adaptation). Although SBS patients commonly exhibit decreased diet-induced diarrhea within the first 2 years after intestinal surgery, very little is known about how the intestinal mucosa adapts in patients with SBS. The proposed pilot study will be the first comprehensive study of serial changes in gut mucosal structure and function in the early period (2-30 months) of SBS in humans. Our Specific Aims are designed to determine: 1) whether the residual small bowel and colonic mucosa in SBS patients exhibits adaptive growth, with concomitantly improved nutrient absorption and gut barrier function; 2) The underlying mechanisms of early gut adaptation in human SBS, by evaluating changes in mucosal cell growth and production of key molecules that are responsible for nutrient transport/absorption and gut barrier function; and 3) The utility of plasma citrulline concentrations and serum flagellin antibody titers as markers for human intestinal absorptive capacity and gut barrier function, respectively. Our research will provide important and new information on the natural history and underlying causes of early intestinal adaptation in man. This information will be valuable in the design of future therapeutic studies in patients with SBS that hold promise for improving the rehabilitation of these individuals.

Conditions

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Short Bowel Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Thomas R. Ziegler, MD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas R Ziegler, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R03DK067123

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0299-2004

Identifier Type: -

Identifier Source: org_study_id