Change in Permeability of the Small Intestine After Treatment With Gluten

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02098057

Collaborator

(none)

Enrollment

Location

Arms

29.6

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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	N/A

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

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 :

Apr 1, 2014

Actual Primary Completion Date :

Sep 19, 2016

Actual Study Completion Date :

Sep 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.

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

Change in permeability of the small intestine after treatment [Baseline to 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

Mayo Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Maria I. Vazquez Roque, M.D., PI, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT02098057

Other Study ID Numbers:

13-005160
FP00074933

First Posted:

Mar 27, 2014

Last Update Posted:

Apr 8, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

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

IBS-diarrhea

Additional relevant MeSH terms:

Gastrointestinal Diseases

Digestive System Diseases

Study Results

No Results Posted as of Apr 8, 2019