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Wheat mystery: which part really upsets IBS sufferers?

NCT ID NCT03664531

Knowledge-focused Sponsor: McMaster University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether purified gluten or whole wheat (which contains gluten plus other proteins) causes stomach and gut symptoms in people with irritable bowel syndrome (IBS). Twenty-nine adults with IBS who had previously felt better on a gluten-free diet took part. They ate special bars containing either purified gluten, whole wheat, or a gluten-free sham bar for one week each, while staying on a gluten-free diet. The goal was to see which bar made their symptoms worse, helping to pinpoint what in wheat might be the real trigger.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
purified gluten and whole wheat (gluten with amylase-trypsin inhibitors)
What this could lead to
If successful, this could help identify which components of wheat cause symptoms in people with irritable bowel syndrome, leading to better dietary advice.
What could go wrong
This is a small, completed trial with only 29 participants, so results may not apply to everyone with IBS. It tests short-term effects, not long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

29 people

The number who actually took part.

Started

Jan 2019

Finished

Jun 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * IBS diagnosis based on Rome IV criteria. * Previously improved while on a gluten-free diet. * Compliance with the study procedures (according to the investigator's own judgement). * Signing the Study Informed Consent form. Exclusion Criteria: * Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection. * Concurrent organic gastrointestinal disease (i.e. Celiac disease, Inflammatory Bowel Disease, peptic ulcer disease, etc.) other than benign polyps, diverticulosis, hemorrhoids, lipoma and melanosis coli. * Major abdominal surgery with the exception of hernia repair, appendectomy, Caesarian section, tubal ligation, cholecystectomy, hysterectomy, and hemorrhoidectomy. * History of active cancer in the last 5 years, other than skin basal cells cancer. * Pregnant or breastfeeding women. * Current use of antibiotics or antibiotic treatment within 1 months before the first visit. * Consumption of probiotics within 1 month prior to the first visit. * Use of non-authorized medications (see Unauthorized Medications section). * Patients on a high fibre diet (\>35 g/day for males, \> 25 g/day for females), consuming high inulin containing foods (\>5 g/day), and/or consuming dietary fibre supplements (as assessed by dietary assessment questionnaire) in the 4 weeks prior to the first visit. * Patients currently participating or having participated in a trial within the past month.

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Irritable bowel syndrome

Contacts and locations

Locations

  • McMaster University Medical Centre

    Hamilton, Ontario, L8N 3Z5, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.