Back to resultsChange in Permeability of the Small Intestine After Treatment With Gluten
Primary Purpose
Gastrointestinal Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gluten Healthy
Placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Disorders focused on measuring IBS-diarrhea
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Gluten
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change in permeability of the small intestine after treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02098057
Brief Title
Change in Permeability of the Small Intestine After Treatment With Gluten
Official Title
A Pilot Study Barrier Function, Intestinal Permeability and Tight Junction Expression in Gluten Sensitive Patients With Functional Gastrointestinal Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 19, 2016 (Actual)
Study Completion Date
September 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Disorders
Keywords
IBS-diarrhea
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Gluten
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten Healthy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in permeability of the small intestine after treatment
Time Frame
Baseline to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria I Vazquez Roque, MD, MSc
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Change in Permeability of the Small Intestine After Treatment With Gluten
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