CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
Purified gluten +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03664531
NCT03664531N/ACompleted
CompareCT.gov

Crossover Trial of Purified Gluten and Whole Wheat (Gluten With Amylase-trypsin Inhibitors) as Triggers of Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome

McMaster University·interventional·Posted Sep 10, 2018·Updated Apr 1, 2026

In Brief

A clinical study evaluating Purified gluten, Non-purified gluten (containing ATIs), and 1 other intervention for Irritable Bowel Syndrome. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 10, 2018
Enrollment StartJan 1, 2019
Primary CompletionApr 1, 2022
Study CompletionJun 20, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.8 years ago

Interventions

Purified glutenother

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

Non-purified gluten (containing ATIs)other

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.

Shamother

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.