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Poop pills could tame tough IBS – early trial underway

NCT ID NCT07481422

Disease control Sponsor: University of Rijeka Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether capsules containing freeze-dried fecal matter from healthy donors can safely reduce symptoms in adults with irritable bowel syndrome (IBS) that hasn't responded to usual treatments. 70 participants will be randomly assigned to receive either the fecal transplant capsules or placebo for three days. Researchers will track symptom severity, quality of life, and side effects over 12 weeks.

What this could mean

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

Active substance
freeze-dried fecal microbiota (from healthy donors) in capsules
What this could lead to
If it works, this could offer a new, non-drug option for people with stubborn IBS that hasn't improved with standard treatments.
What could go wrong
This is an early phase 1/2 trial with only 70 people, so results may not apply to everyone. The treatment involves swallowing donor stool material, which carries unknown long-term risks.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 70 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 65 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: * 18-65 years of age * disease activity defined by an IBS-Symptom Severity Score (IBS-SSS) of more than 175 * symptoms refractory to conservative medical therapy (hyoscine salts, osmotic laxatives such as polyethylene glycol, loperamide, rifaximin, tricyclic antidepressants, SSRIs or other antidepressants, peppermint oil) * negative evaluation for coeliac disease * signed informed consent Exclusion Criteria: * pregnant or breastfeeding women * women of childbearing potential who are unwilling to use an acceptable method of birth control * severely immunocompromised or immunosuppressed (organ transplant recipients, those with neutropenia with an absolute neutrophil count of \<500 cells per mm3, those receiving current treatment with antineoplastic drugs, HIV positive) * gastrointestinal symptoms explained by an alternative diagnosis (underlying IBD, infectious enteritis) * severe allergy to capsule components * therapy with new antidepressants or had a change in antidepressant dose within previous 3 months * serious medical comorbidities (including neurological or psychiatric comorbidities) * treatment with antibiotics 3 months before enrolment * previous history of FMT at any time in the past * unwillingness to ingest the capsules

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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 (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

  • Clinical Hospital Center Rijeka

    RECRUITING

    Rijeka, 51000, Croatia

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