Change in Permeability of the Small Intestine After Treatment With Gluten

A Pilot Study Barrier Function, Intestinal Permeability and Tight Junction Expression in Gluten Sensitive Patients With Functional Gastrointestinal Disorders

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).

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Disorders
• Intervention / Treatment: Drug: Placebo; Dietary supplement: Gluten Healthy

Detailed Description

The specific aim of this hypothesis-generating, pilot study is to randomize (like the flip of a coin) patients who have Non Celiac Gluten Sensitivity to a 4-week Gluten-containing diet (GCD) or to a Gluten free diet (GFD). The study will evaluate small bowel (SB) permeability functionally (2-sugar differential excretion), morphologically, using probe-based confocal laser to evaluate the small intestinal, as well as molecularly, using tight junction (TJ) messenger RNA (mRNA) expression in small bowel mucosa in response to the different diets.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; A total of 24 patients with NCGS and 12 healthy controls will be recruited for this study. The 24 patients with NCGS will be randomized to receive one of two diets (GFD or GCD) in a 1:1 ratio	Drug: Placebo; A total of 24 patients with NCGS and 12 healthy controls will be recruited for this study. The 24 patients with NCGS will be randomized to receive one of two diets (GFD or GCD) in a 1:1 ratio Assessment of current diet and amount of gluten consumed will be determined by the dietitian and by means of a questionnaire at baseline. Subjects will have a 2-week run in period, in which they will continue or initiate a gluten free diet plan prepared by the dietitians. After the run-in period, participants will be randomized to either a gluten containing diet (GCD) or placebo (GFD) for 4 weeks.
Active Comparator: Gluten; A total of 24 patients with NCGS and 12 healthy controls will be recruited for this study. The 24 patients with NCGS will be randomized to receive one of two diets (GFD or GCD) in a 1:1 ratio	Dietary supplement: Gluten Healthy; Assessment of current diet and amount of gluten consumed will be determined by the dietitian and by means of a questionnaire at baseline. Subjects will have a 2-week run in period, in which they will continue or initiate a gluten free diet plan prepared by the dietitians. After the run-in period, participants will be randomized to either a gluten containing diet (GCD) or placebo (GFD) for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in permeability of the small intestine after treatment	Baseline to 4 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Maria I Vazquez Roque, MD, MSc, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 19, 2016
• Study Completion (Actual): September 19, 2016

Study Registration Dates

• First Submitted: March 14, 2014
• First Submitted That Met QC Criteria: March 24, 2014
• First Posted (Estimate): March 27, 2014

Study Record Updates

• Last Update Posted (Actual): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: IBS-diarrhea
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 13-005160; FP00074933 (Other Identifier: CRT-1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share Individual Patient Data at this time. Once data analysis is done at study conclusion, it will help determine feasibility for moving forward with another, similar - possibly larger, study. That said, data may be released after study conclusion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No