Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome
|ClinicalTrials.gov Identifier: NCT01094041|
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : May 10, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea Diarrhea Predominant Irritable Bowel Syndrome||Other: Gluten free diet Other: Gluten rich diet||Not Applicable|
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:
- Stool samples to check markers of inflammation such as fecal calprotectin.
- Blood samples to check markers of inflammation and for genetic testing.
- After ingestion of the mannitol, lactulose and sucralose sugars, urine samples to indirectly measure small intestinal and colonic permeability.
- After sedation, upper gastrointestinal endoscopy and flexible sigmoidoscopy to obtain 6 mucosal biopsies from the small bowel and sigmoid colon for immunohistochemical analysis.
- Scintigraphy to measure gastrointestinal transit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Gluten Intolerance in Irritable Bowel Syndrome With Diarrhea: The Role of HLA-DQ2|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2013|
|Experimental: Gluten free diet||
Other: Gluten free diet
A 4-week gluten free diet provided
|Experimental: Gluten rich diet||
Other: Gluten rich diet
A 4-week gluten rich diet is provided
- Small bowel permeability [ Time Frame: 0 - 2 hours post sugar ingestion ]Excretion of mannitol 0-2 hours after liquid formulation
- Colonic permeability [ Time Frame: 2 -24 hours post sugars ingestion ]Cumulative excretion of mannitol at 2-24 hours after liquid
- Colonic transit [ Time Frame: 24 hours ]Colonic transit geometric center at 24 hours
- Colon transit [ Time Frame: 6-12 hours ]Ascending colon emptying T1/2
- Colonic permeability [ Time Frame: 2-24 hours after sugars ingestion ]Cumulative excretion of lactulose
- Colonic permeability [ Time Frame: 8 to 24 hours after ingestion of sugars ]Hourly excretion of mannitol
- Small bowel transit time [ Time Frame: 6 hours ]Colonic filling at 6 hours (%)
- Gastric emptying [ Time Frame: 0-2 hours ]Gastric emptying T1/2
- Colonic inflammatory response [ Time Frame: 4 weeks ]Sigmoid colon mucosal immunocyte count in lamina propria
- Stool frequency and consistency [ Time Frame: 6 weeks ]Bowel pattern diary
- Small bowel inflammatory response [ Time Frame: 4 weeks ]Duodenal mucosal immunocyte count in lamina propria
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094041
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Michael Camilleri, MD||Mayo Clinic|