Gastrointestinal Disorders Clinical Trial
Official title:
A Pilot Study Barrier Function, Intestinal Permeability and Tight Junction Expression in Gluten Sensitive Patients With Functional Gastrointestinal Disorders
Verified date | April 2019 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall hypothesis of this research study is that gluten intake alters intestinal barrier function in patients with Irritable Bowel Syndrome (IBS) diarrhea who also exhibit non-celiac gluten sensitivity (NCGS).
Status | Completed |
Enrollment | 20 |
Est. completion date | September 19, 2016 |
Est. primary completion date | September 19, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Non celiac gluten sensitive patients with a functional bowel disorder 2. Age 18 to 70 years. Exclusion Criteria: 1. Positive serum tissue transglutaminase (TTG) Immunoglobulin A (IgA) 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. Abdominal surgeries (except appendectomy, cholecystectomy and vaginal hysterectomy or tubal ligation) 4. Use of Nonsteroidal Anti-inflammatory Drugs(NSAIDs) or aspirin within the past week (since Nonsteroidal Anti-inflammatory Drugs (NSAIDs) affect intestinal permeability). 5. Use of oral corticosteroids within the previous 6 weeks. 6. Ingestion of artificial sweeteners such as Sucralose, Nutrasweet ™ (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g., foods to be avoided are sugarless gums or mints and diet soda. 7. Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies. 8. High anxiety or depression score (>11 on each subscale) on the Hospital Anxiety Depression Score questionnaire. 9. Known allergy to fluorescein. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in permeability of the small intestine after treatment | Baseline to 4 weeks |
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