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FODMAPs infused into colon: new clues for IBS?

NCT ID NCT06488534

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looked at how FODMAPs—carbohydrates that can cause bloating and gas—affect the movement of the colon and related symptoms. Fifteen healthy volunteers received FODMAPs directly into the colon during three separate visits. The goal was to measure colon pressure changes and track any abdominal symptoms, helping researchers better understand what triggers IBS.

What this could mean

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

Active substance
FODMAPs (fermentable carbohydrates)
What this could lead to
If successful, this could help explain how certain foods trigger IBS symptoms, potentially guiding future dietary therapies.
What could go wrong
This is a small, early study in healthy volunteers, not patients. Results may not apply to people with IBS or lead directly to treatments.

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

15 people

The number who actually took part.

Started

Jun 2023

Finished

Dec 2024

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

Accepted

You do not need to have the condition being studied to take part.

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: * Subjects should provide written informed consent to participate in the study * Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 years without spontaneous menses. * Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements. * Healthy volunteers should consider themselves healthy and should not be medically examined Exclusion Criteria: * History of major surgery of the gastrointestinal tract (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed). * Known underlying organic gastrointestinal disease, including intestinal obstruction, ileus, intestinal perforation, severe inflammatory disorder like ulcerative colitis, Crohn's disease or toxic megacolon * Diabetes mellitus types 1 and 2 * Concomitant Kidney or Liver disease, Biliary obstruction * Decreased cardiac -or respiratory function * Pregnant or breastfeeding women * Use of antibiotics in the past month * History of skin allergies or a history of extreme sensitivity to cosmetics or lotions * Fragile skin vulnerable to skin tears. * Damaged epigastric skin (open wounds, rash, inflammation) * Subjects who are unable to remain in a relaxed reclined position for the test duration * Subject has received an investigational drug or used an investigational medical device within 30 days prior to randomization, or is currently enrolled in an investigational study. * The use of following drugs 1 month prior to inclusion and during the whole study duration: laxatives, opioids, anti-acids, anticholinergics/antispasmodics, anticonvulsants, antidepressants, diuretics, antihypertensives, antipsychotics, calcium channel blockers, bile acid sequestrants, iron supplements, anticoagulants, HIV protease inhibitors (saquinavir, lopinavir), atorvastatine, negazodone, efavirenz, Sint-janskruid (CYP3A4 inducers)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • KU Leuven

    Leuven, Vlaams-Brabant, 3000, Belgium

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