Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Diarrhea; Diarrhea Predominant Irritable Bowel Syndrome
• Interventions: Other: Gluten free diet; Other: Gluten rich diet

• Registration Number: NCT01094041
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Primary Completion: 2012-01
• Study Completion: 2013-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-08
• Last Update Posted: 2013-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gluten free diet	Gluten free diet	-
Gluten rich diet	Gluten rich diet	-

Primary Outcome Measures

Name	Time	Method
Small bowel permeability	0 - 2 hours post sugar ingestion	Excretion of mannitol 0-2 hours after liquid formulation
Colonic permeability	2 -24 hours post sugars ingestion	Cumulative excretion of mannitol at 2-24 hours after liquid
Colonic transit	24 hours	Colonic transit geometric center at 24 hours

Secondary Outcome Measures

Name	Time	Method
Gastric emptying	0-2 hours	Gastric emptying T1/2
Small bowel inflammatory response	4 weeks	Duodenal mucosal immunocyte count in lamina propria
Stool frequency and consistency	6 weeks	Bowel pattern diary
Colon transit	6-12 hours	Ascending colon emptying T1/2
Colonic permeability	8 to 24 hours after ingestion of sugars	Hourly excretion of mannitol
Small bowel transit time	6 hours	Colonic filling at 6 hours (%)
Colonic inflammatory response	4 weeks	Sigmoid colon mucosal immunocyte count in lamina propria

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States