Change in Permeability of the Small Intestine After Treatment With Gluten

• ClinicalTrials.gov Identifier: NCT02098057
• Recruitment Status: Completed
• First Posted: March 27, 2014
• Last Update Posted: April 8, 2019
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Maria I. Vazquez Roque, M.D., Mayo Clinic

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Gastrointestinal Disorders	Dietary Supplement: Gluten Healthy; Drug: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: A Pilot Study Barrier Function, Intestinal Permeability and Tight Junction Expression in Gluten Sensitive Patients With Functional Gastrointestinal Disorders
• Study Start Date: April 2014
• Actual Primary Completion Date: September 19, 2016
• Actual Study Completion Date: September 19, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in permeability of the small intestine after treatment [ Time Frame: Baseline to 4 weeks ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Florida

Mayo Clinic

Jacksonville, Florida, United States, 32224

Sponsors and Collaborators

Mayo Clinic

Investigators

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

More Information

• Responsible Party: Maria I. Vazquez Roque, M.D., PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02098057
• Other Study ID Numbers: 13-005160; FP00074933 ( Other Identifier: CRT-1 )
• First Posted: March 27, 2014
• Last Update Posted: April 8, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maria I. Vazquez Roque, M.D., Mayo Clinic:

IBS-diarrhea

Additional relevant MeSH terms:

Digestive System Diseases; Gastrointestinal Diseases