Overview
Change in Permeability of the Small Intestine After Treatment With Gluten
Status:
Completed
Completed
Trial end date:
2016-09-19
2016-09-19
Target enrollment:
0
0
Participant gender:
All
All
Summary
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).Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Mayo Clinic
Criteria
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.