Change in Permeability of the Small Intestine after Treatment

  • Study type:

    Interventional What is this?

    Describes 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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 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.
  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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Maria Vazquez Roque, M.D.

Open for enrollment

Johnathan Wright C.C.R.C.

(904)953-7521

Wright.Jonathan@mayo.edu