Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome

Mayo Clinic

Status: Completed

Conditions: Diarrhea; Diarrhea Predominant Irritable Bowel Syndrome

Treatments: Other: Gluten rich diet; Other: Gluten free diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01094041

09-007344

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Gluten free diet

Experimental group

Treatment:

Other: Gluten free diet

Gluten rich diet

Experimental group

Treatment:

Other: Gluten rich diet