NCT03492333: GFD_IBS

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

Completed NA Last updated 10 April 2018

What this trial tests

NA trial testing Gluten free diet in IBS - Irritable Bowel Syndrome in 75 participants. Completed in 30 May 2016.

Timeline

30 April 2012

Primary endpoint
30 May 2016

30 May 2016

Quick facts

Lead sponsor	McMaster University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	75
Start date	30 April 2012
Primary completion	30 May 2016
Estimated completion	30 May 2016
Sites	1 location across Canada

Drugs / interventions tested

• Gluten free diet

Conditions studied

• IBS - Irritable Bowel Syndrome — all drugs for IBS - Irritable Bowel Syndrome →

Sponsor

McMaster University

Who can join

Adults 18 to 75, any sex, with IBS - Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gluten-Free Diet Reduces Symptoms, Particularly Diarrhea, in Patients With Irritable Bowel Syndrome and Antigliadin IgG.
   Pinto-Sanchez MI, Nardelli A, Borojevic R, De Palma G, et al · · 2021 · cited 39× · PMID 32827724 · DOI 10.1016/j.cgh.2020.08.040
2. Fecal microbiome differs between patients with systemic sclerosis with and without small intestinal bacterial overgrowth.
   Levin D, De Palma G, Zou H, Bazzaz AHZ, et al · · 2021 · cited 12× · PMID 35382497 · DOI 10.1177/23971983211032808