Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome
Completed · Not applicable
Conditions studied: Diarrhea, Diarrhea Predominant Irritable Bowel Syndrome
In brief
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.
Key facts
- Study ID
- NCT01094041
- Run by
- Mayo Clinic
- People needed
- 50
- Starts
- 2010-02-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2013-05-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diarrhea or diarrhea predominant IBS patients
- Age 18 to 65
- BDQ confirms presence of IBS-D or functional diarrhea, positive by Rome III criteria
- No restrictions on Hospital Anxiety Depression score
- No abdominal surgery (except appendectomy and cholecystectomy)
You may not qualify if…
- Serum tissue transglutaminase IgA or IgG positive or medical record of small bowel biopsy suggestive of celiac disease
- Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)
- Use of oral corticosteroids within the previous 6 weeks
- 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
- Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins.
- Any females who are pregnant or trying to become pregnant (due to radiation exposure)
- Bleeding disorders or medications that increase risk of bleeding from mucosal
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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