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Gut bacteria and food triggers: new clues for IBS sufferers

NCT ID NCT04364750

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at why certain foods cause symptoms in people with Irritable Bowel Syndrome (IBS). Researchers focused on how gut bacteria produce histamine when digesting specific carbohydrates (FODMAPs). Thirty adults with IBS followed a low-FODMAP diet and took special drinks and probiotics to measure changes in bacteria and symptoms.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

30 people

The number who actually took part.

Started

Jul 2021

Finished

Feb 2026

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 to 75 years

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: * Adults aged 18-75 with IBS (Rome IV criteria) who have self-reported previous improvement in their IBS symptoms while on a low FODMAP diet, or when excluding certain high-FODMAP foods, or patients in whom histamine is expected to play a key role (either diagnosed with high histamine producing bacteria, or improved IBS symptoms after using antihistamines). Individuals should be able to swallow size 00 capsules. Exclusion Criteria: * Concurrent significant organic GI pathology (i.e. celiac, IBD, etc.) * Concurrent systemic disease (such as diabetes) and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection * History of active cancer in the last 5 years, other than basal cell cancer * Pregnant or breastfeeding women * Active or recent participation (\< 1 month) in a clinical study, except for SPOR IMAGINE * Use of antibiotics, probiotics, or ACE inhibitors during, or one month prior to the study * Use of new medications less than 4 weeks prior to the study. * Allergies to any of the ingredients used in the study * Any immune-compromising conditions

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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

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7, Canada

  • McMaster University Medical Centre

    Hamilton, Ontario, L8N 3Z5, Canada

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