Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome



Status:Archived
Conditions:Irritable Bowel Syndrome (IBS), Endocrine, Gastrointestinal
Therapuetic Areas:Endocrinology, Gastroenterology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:February 2010
End Date:December 2012

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Gluten Intolerance in Irritable Bowel Syndrome With Diarrhea: The Role of HLA-DQ2


The specific hypotheses are:

Gluten supplementation for four weeks increases small intestinal permeability and
accelerates colonic transit in patients with irritable bowel syndrome with diarrhea (IBS-D)
or functional diarrhea (FD) who are HLA-DQ2 positive.


The study design is a double-blind, randomized, controlled, parallel-group, 6-week study
comparing the effects of gluten rich versus gluten free diets in diarrhea or diarrhea
predominant IBS patients. All participants will keep a daily bowel pattern diary throughout
the study. All participants will have negative serum tissue transglutaminase (TTg) assay,
and anti-endomysial antibody test, if TTg is positive or equivocal. All participants will
have the following studies performed both before and after the 4-week dietary intervention:

1. Stool samples to check markers of inflammation such as fecal calprotectin.

2. Blood samples to check markers of inflammation and for genetic testing.

3. After ingestion of the mannitol, lactulose and sucralose sugars, urine samples to
indirectly measure small intestinal and colonic permeability.

4. After sedation, upper gastrointestinal endoscopy and flexible sigmoidoscopy to obtain 6
mucosal biopsies from the small bowel and sigmoid colon for immunohistochemical
analysis.

5. Scintigraphy to measure gastrointestinal transit.


We found this trial at
1
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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