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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03492333
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Information provided by (Responsible Party):
McMaster University

Brief Summary:

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

Condition or disease Intervention/treatment Phase
IBS - Irritable Bowel Syndrome Other: Gluten free diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Intervention GFD in IBS and HV(controls)
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Antigliadin Antibodies in Predicting the Beneficial Effect of Gluten Free Diet in Unselected IBS Patients
Actual Study Start Date : April 30, 2012
Actual Primary Completion Date : May 30, 2016
Actual Study Completion Date : May 30, 2016

Arm Intervention/treatment
Experimental: Gluten free diet
Single arm
Other: Gluten free diet
Gluten-free diet- Instructions provided by a dietitian

Primary Outcome Measures :
  1. Improvement on gastrointestinal symptoms [ Time Frame: 4 weeks ]
    Decrease >2 points IBS Birmingham score

Secondary Outcome Measures :
  1. Normalization of gastrointestinal transit [ Time Frame: 4 weeks ]
    (SHAPE 25-50 radiopaque markers)

  2. Improvement anxiety and/or depression [ Time Frame: 4 weeks ]
    Decrease >2 points Hospital anxiety and depression (HAD) score

  3. Improvement somatization [ Time Frame: 4 weeks ]
    Decrease somatization scores (PHQ15)

  4. Improvement quality of life and well-being [ Time Frame: 4 weeks ]
    Decrease in the psychological general well-being (PGWB) score

  5. Changes in gut microbiota [ Time Frame: 4 weeks ]
    changes in microbial composition

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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): NCT03492333

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Canada, Ontario
Farncombe Institute
Hamilton, Ontario, Canada, L8S4K1
Sponsors and Collaborators
McMaster University
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Principal Investigator: Premysl Bercik, MD McMaster University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03492333    
Other Study ID Numbers: AGA_GFD_in_IBS
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data.

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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 McMaster University:
antigliadin, gluten free diet, transit
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases