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Scientists hunt for the exact FODMAPs that trigger IBS pain

NCT ID NCT07688044

Symptom relief Sponsor: David Reed Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This study investigates which specific types of FODMAPs (carbohydrates found in many foods) cause abdominal pain in people with irritable bowel syndrome (IBS). Participants follow a low-FODMAP diet and then add back individual FODMAP subtypes to see which ones worsen pain. Stool samples and lab-grown gut bacteria help determine whether the pain is driven by gut microbes or by the FODMAPs themselves. The goal is to make dietary therapy for IBS more targeted and easier to follow.

What this could mean

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

Active substance
FODMAP dietary challenge (specific carbohydrate subtypes)
What this could lead to
If successful, this could identify which FODMAPs trigger pain in IBS, allowing patients to avoid only those foods instead of a restrictive low-FODMAP diet.
What could go wrong
This is an early-stage, small study (60 participants) focused on mechanisms, not a treatment. Results may not apply to all IBS patients, and dietary challenges could temporarily worsen 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

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2031

An estimate. End dates often move.

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 70 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 18-70 with IBS (Rome IV (now V) criteria) * PROMIS belly pain score \>12 Exclusion Criteria: 1. Concurrent significant organic GI pathology (i.e. celiac, IBD, etc.) as some symptoms may be related to their disease and not IBS. 2. Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection. 3. Major gastrointestinal surgery (e.g. Roux en y, bowel resection) as symptoms may be related to previous surgery rather than IBS. 4. Body mass index above 35 kg/m2 as it is unknown how mediators in the GI tract that may be involved in pain signaling in the gut are affected by obesity. 5. History of active cancer in the last 5 years, other than basal cell cancer as the treatment may have impacted the GI tract. 6. Pregnant or breastfeeding women. 7. Active or recent participation (\< 1 month) in a clinical study. 8. Use of antibiotics, probiotics, during, or one month prior to the study as may affect gut microbiota. 9. Use of new medications less than 4 weeks prior to the study as may alter gut microbiota and/or IBS symptoms. 10. Allergies to any of the ingredients used in the study. 11. Any immune-compromising conditions as may affect GI symptoms. 12. Currently being treated for eating disorder, schizophrenia, psychosis or other acute mental disorders as participating in a diet challenge study may have negative impact on these disorders.

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Conditions

The condition(s) this trial relates to.

Abdominal Pain irritable bowel syndrome

As listed by the trial registrant

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

Irritable bowel syndrome (IBS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hotel Dieu Hospital

    RECRUITING

    Kingston, Ontario, K7L 5G2, Canada

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