Change in Permeability of the Small Intestine After Treatment With Gluten

Completed · Not applicable · Has a placebo group

Conditions studied: Gastrointestinal Disorders

In brief

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).

Key facts

Study ID

NCT02098057

Run by

Mayo Clinic

People needed

20

Starts

2014-04-01

Expected to finish

2016-09-19

Last updated by the study team

2019-04-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Non celiac gluten sensitive patients with a functional bowel disorder
• Age 18 to 70 years.

You may not qualify if…

• 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 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.

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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