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Dietary Triggers of Gastrointestinal Symptoms in IBS Patients

NCT03664531 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-04-01

Study results available
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Summary

This crossover randomized controlled trial will evaluate the effects of purified gluten and whole wheat (gluten combined with amylase-trypsin inhibitors (ATIs)) on inducing intestinal and extra-intestinal symptoms in irritable bowel syndrome (IBS) patients. All participants will be put on a gluten-free diet and then challenged with muesli bars containing either purified gluten, whole wheat (gluten with ATIs), or gluten-free sham.

Conditions

  • Irritable Bowel Syndrome

Interventions

OTHER

Purified gluten

1 low FODMAPs, vegan muesli bar containing purified gluten per day for 1 week, for a total of 10 g purified gluten per day.

OTHER

Non-purified gluten (containing ATIs)

1 low FODMAPs, vegan muesli bar containing whole wheat flour with non-purified gluten per day for 1 week, for a total of 10 g non-purified gluten per day.

OTHER

Sham

1 gluten-free, ATI-free, low FODMAPs, vegan muesli bar per day for 1 week. This is a sham because participants were blinded to the identity of this gluten-free control and randomly assigned to it.

Sponsors & Collaborators

Principal Investigators

  • Premysl Bercik, MD · McMaster University

  • Maria Ines Pinto-Sanchez, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-04-01
Completion
2023-06-20

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03664531 on ClinicalTrials.gov