A Study of Gluten Intolerance in Patients with Diarrhea Predominant Irritable Bowel Syndrome
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 09-007344
NCT ID: NCT01094041
Sponsor Protocol Number: 09-007344
About this study
The purpose of this study is to test gluten supplementation for four weeks, to see if it increases small intestinal permeability and accelerates colonic transit in patients who have irritable bowel syndrome with diarrhea (IBS-D) or functional diarrhea (FD) who are HLA-DQ2 positive.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Diarrhea or diarrhea predominant IBS patients
- Age 18 to 65
- BDQ confirmed 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)
Exclusion Criteria
- Serum tissue transglutaminase IgA or IgG positive
- 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 mucosa
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Michael Camilleri, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available