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Change in Permeability of the Small Intestine After Treatment With Gluten

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

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.

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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

Resource links provided by the National Library of Medicine


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.




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


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098057


Locations
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United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Maria I Vazquez Roque, MD, MSc Mayo Clinic
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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    Key Record Dates
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.

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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:
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Digestive System Diseases
Gastrointestinal Diseases