Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|