Mechanisms of Adaptation in Human Short Bowel Syndrome

NCT00248573 | Completed

• 2 other identifiers: 0299-2004R03DK067123
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• intestinal gene expression

  2011-2012

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1\) Adults aged 18-75 with less than 200cm small bowel remaining after latest(SBR); 2) Subject able to enter the study within 2-24 months of latest SBR; 3)(BMI) ≥ 17 kg/m2; 4) Subject is living at home, clinically stable and expected to survive at least one year; 5) Subject able to take some oral solid diet and oral medications; 6) 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); 7) 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); 8) Subject has the ability to understand the requirements of the study, provide written informed consent and agrees to participate in all assessments.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Intestinal biopsy samples

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas R Ziegler, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 4, 2005
• Study Start: October 1, 2004
• Primary Completion: September 1, 2012
• Study Completion: July 1, 2013
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

US (2)