Gluten Free Diet in IBS Patients Stratified According to Their Antigliadin Status (GFD_IBS)

April 3, 2018 updated by: McMaster University

The Role of Antigliadin Antibodies in Predicting the Beneficial Effect of Gluten Free Diet in Unselected IBS Patients

Gluten-free diet has been shown to improve gut symptoms in patients with celiac disease and also in adult patients with diagnosis of Irritable Bowel Syndrome (Rome III criteria).

Antibodies to native gliadin (AGA) have been suggested as a potential diagnostic marker of response to GFD. However, this has not been tested in a prospective study in IBS patients. Identification of predictors of a symptomatic response to GFD within the IBS population would improve the clinical management of these patients.

The purpose of this study is to evaluate the effect of gluten-free diet on gastrointestinal symptoms and gut motility in patients with Irritable Bowel Syndrome stratified according to their antigliadin antibodies status.

Additional purposes include investigating effects gluten free diet may have on other parameters:

  • Improvement of mood
  • Quality of life and general well-being
  • Changes in gut microbiota

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S4K1
        • Farncombe Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients
  • IBS diagnosis (Rome III)
  • Willingness to participate

Exclusion Criteria:

  • history of any organic disease including celiac disease
  • Immune deficiency
  • Major abdominal surgery
  • Use of immunosuppressants, glucocorticosteroids or opioids
  • Use of antibiotics in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gluten free diet
Single arm
Other: Gluten free diet
Gluten-free diet- Instructions provided by a dietitian

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement on gastrointestinal symptoms
Time Frame: 4 weeks
Decrease >2 points IBS Birmingham score
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normalization of gastrointestinal transit
Time Frame: 4 weeks
(SHAPE 25-50 radiopaque markers)
4 weeks
Improvement anxiety and/or depression
Time Frame: 4 weeks
Decrease >2 points Hospital anxiety and depression (HAD) score
4 weeks
Improvement somatization
Time Frame: 4 weeks
Decrease somatization scores (PHQ15)
4 weeks
Improvement quality of life and well-being
Time Frame: 4 weeks
Decrease in the psychological general well-being (PGWB) score
4 weeks
Changes in gut microbiota
Time Frame: 4 weeks
changes in microbial composition
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 30, 2012

Primary Completion (ACTUAL)

May 30, 2016

Study Completion (ACTUAL)

May 30, 2016

Study Registration Dates

First Submitted

April 3, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (ACTUAL)

April 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGA_GFD_in_IBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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