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

Not Applicable

Completed

• Conditions: IBS - Irritable Bowel Syndrome
• Interventions: Other: Gluten free diet

• Registration Number: NCT03492333
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-30
• Primary Completion: 2016-05-30
• Study Completion: 2016-05-30
• Status Verified: 2017-07
• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-03
• Last Update Submitted: 2018-04-03
• Study First Posted: 2018-04-10
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gluten free diet	Gluten free diet	Single arm

Primary Outcome Measures

Name	Time	Method
Improvement on gastrointestinal symptoms	4 weeks	Decrease \>2 points IBS Birmingham score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Farncombe Institute; 🇨🇦 Hamilton, Ontario, Canada