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

NCT ID: NCT03492333

Last Updated: 2018-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-05-30

Brief Summary

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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

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Conditions

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IBS - Irritable Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Intervention GFD in IBS and HV(controls)
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Gluten free diet

Single arm

Group Type EXPERIMENTAL

Gluten free diet

Intervention Type OTHER

Gluten-free diet- Instructions provided by a dietitian

Interventions

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Gluten free diet

Gluten-free diet- Instructions provided by a dietitian

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Premysl Bercik, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Farncombe Institute

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Pinto-Sanchez MI, Nardelli A, Borojevic R, De Palma G, Calo NC, McCarville J, Caminero A, Basra D, Mordhorst A, Ignatova E, Hansen S, Uhde M, Norman GL, Murray JA, Smecuol E, Armstrong D, Bai JC, Schuppan D, Collins SM, Alaedini A, Moayyedi P, Verdu EF, Bercik P. Gluten-Free Diet Reduces Symptoms, Particularly Diarrhea, in Patients With Irritable Bowel Syndrome and Antigliadin IgG. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2343-2352.e8. doi: 10.1016/j.cgh.2020.08.040. Epub 2020 Aug 19.

Reference Type DERIVED
PMID: 32827724 (View on PubMed)

Other Identifiers

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AGA_GFD_in_IBS

Identifier Type: -

Identifier Source: org_study_id

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