Change in Permeability of the Small Intestine after Treatment
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
- Jacksonville, Florida: 13-005160
NCT ID: NCT02098057
Sponsor Protocol Number: 13-005160
About this study
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).
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:
- Non celiac gluten sensitive patients with a functional bowel disorder
- Age 18 to 70 years.
Exclusion Criteria:
- Positive serum tissue transglutaminase (TTG) Immunoglobulin A (IgA) 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).
- Abdominal surgeries (except appendectomy, cholecystectomy and vaginal hysterectomy or tubal ligation)
- Use of Nonsteroidal Anti-inflammatory Drugs(NSAIDs) or aspirin within the past week (since Nonsteroidal Anti-inflammatory Drugs (NSAIDs) affect intestinal permeability).
- Use of oral corticosteroids within the previous 6 weeks.
- Ingestion of artificial sweeteners such as Splenda™ (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.
- Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
- High anxiety or depression score (>11 on each subscale) on the Hospital Anxiety Depression Score questionnaire.
- Known allergy to fluorescein.
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 |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Maria Vazquez Roque, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available