Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome

NCT ID: NCT01094041

Last Updated: 2013-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-01-31

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.

Conditions

Diarrhea; Diarrhea Predominant Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Gluten free diet

Group Type: EXPERIMENTAL

Gluten free diet

Intervention Type: OTHER

A 4-week gluten free diet provided

Gluten rich diet

Group Type: EXPERIMENTAL

Gluten rich diet

Intervention Type: OTHER

A 4-week gluten rich diet is provided

Interventions

Gluten free diet

A 4-week gluten free diet provided

Intervention Type: OTHER

Gluten rich diet

A 4-week gluten rich diet is provided

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Diarrhea or diarrhea predominant IBS patients

2. Age 18 to 65

3. BDQ confirms presence of IBS-D or functional diarrhea, positive by Rome III criteria

4. No restrictions on Hospital Anxiety Depression score

5. No abdominal surgery (except appendectomy and cholecystectomy)

Exclusion Criteria

1. Serum tissue transglutaminase IgA or IgG positive or medical record of small bowel biopsy suggestive of celiac disease

2. Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)

3. Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)

4. Use of oral corticosteroids within the previous 6 weeks

5. Ingestion of artificial sweeteners such as SplendaTM (sucralose), Nutrasweet TM(aspartame), lactulose or mannitol 2 days before the study begins, e.g., foods to be avoided are sugarless gums or mints and diet soda

6. Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins.

7. Any females who are pregnant or trying to become pregnant (due to radiation exposure)

8. Bleeding disorders or medications that increase risk of bleeding from mucosal

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Michael Camilleri, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Vazquez-Roque MI, Camilleri M, Smyrk T, Murray JA, Marietta E, O'Neill J, Carlson P, Lamsam J, Janzow D, Eckert D, Burton D, Zinsmeister AR. A controlled trial of gluten-free diet in patients with irritable bowel syndrome-diarrhea: effects on bowel frequency and intestinal function. Gastroenterology. 2013 May;144(5):903-911.e3. doi: 10.1053/j.gastro.2013.01.049. Epub 2013 Jan 25.

Reference Type: DERIVED

PMID: 23357715 (View on PubMed)

Other Identifiers

09-007344

Identifier Type: -

Identifier Source: org_study_id