Status:
COMPLETED
Mechanisms of Adaptation in Human Short Bowel Syndrome
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Short Bowel Syndrome
Eligibility:
All Genders
18-75 years
Brief Summary
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 mon...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 1) Adult male or female with less than 200 small bowel remaining after latest small bowel resection (SBR); 2) Subject able to enter the study within 2-24 months of latest SBR; 3) Age 18-75 years; 4) Body mass index (BMI) ≥ 17 kg/m2; 5) Subject is living at home, clinically stable and expected to survive at least one year; 6) Subject able to take some oral solid diet and oral medications; 7) Intact stomach and duodenum and at least 30 cm of in-continuity jejunum and/or ileum (presence of residual colon is not a specific eligibility criterion); 8) Accurate records available on residual small bowel/colonic length (accurate tape measurement in operation room or small bowel follow-through performed within 3 months of entry); 9) Subject has the ability to understand the requirements of the study, provide written informed consent and agrees to participate in all GCRC assessments.
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Exclusion
- 1) Evidence of active malignancy during the past 5 years (with the exception of non-metastatic skin cancer; 2) Evidence of uncontrolled hypertension, congestive heart failure, myocardial infarction or angina; 3) History or evidence of stroke or clinically serious neurologic dysfunction since last SBR; 4) Evidence of acute infectious illness requiring hospitalization within the previous 4 weeks; 5) History of steroid-or oxygen-dependent lung disease; 6) History of mental deficiency, alcoholism, or other substance abuse problems; 7) Pregnancy or lactation ; 8) Evidence of worsening of Crohn's disease within 2 months prior to study (i.e. worsening diarrhea, new abdominal pain, rectal bleeding, and, when clinically applicable, abnormal radiographic and/or endoscopic findings); 9) Condition requiring daily systemic corticosteroids exceeding a dose equivalent to 10 mg/d of prednisone or significant immunosuppressant therapy (with the exception of Crohn´s disease); 11) Subject has received glutamine or growth hormone within 2 months prior to study.
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Key Trial Info
Start Date :
October 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00248573
Start Date
October 1 2004
End Date
July 1 2013
Last Update
December 17 2013
Active Locations (2)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213