NCT03869359: PROT-IBS

The Effect of Gluten in Patients With Irritable Bowel Syndrome and Healthy Volunteers

Completed NA Last updated 22 October 2020

What this trial tests

NA trial testing Gluten-free diet with gluten powder in Irritable Bowel Syndrome in 40 participants. Completed in 1 October 2019.

Timeline

1 October 2018

Primary endpoint
1 October 2019

1 October 2019

Quick facts

Lead sponsor	Sahlgrenska University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	supportive care
Enrollment	40
Start date	1 October 2018
Primary completion	1 October 2019
Estimated completion	1 October 2019
Sites	1 location across Sweden

Drugs / interventions tested

• Gluten-free diet with gluten powder
• Gluten-free diet with placebo powder

Conditions studied

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

Sponsor

Sahlgrenska University Hospital

Who can join

Adults 18 to 85, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with Irritable Bowel Syndrome (IBS) often link their symptoms to foods. Interest in dietary management recently increased, including the use of a gluten-free diet.

To investigate relation of gluten-free diet (GFD) and IBS, a randomized, double-blind, placebo-controlled cross-over trial will be carried out in adults (\>18) and patients with IBS according to Rome IV criteria. The aim is to assess gluten-free versus gluten-containing diet in IBS patients and Healthy Volunteers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomised controlled trial: effects of gluten-free diet on symptoms and the gut microenvironment in irritable bowel syndrome.
   Algera JP, Magnusson MK, Öhman L, Störsrud S, et al · · 2022 · cited 22× · PMID 36173041 · DOI 10.1111/apt.17239