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Poop pills: does donor selection make or break IBS treatment?

NCT ID NCT06171126

Symptom relief Sponsor: Haukeland University Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether the donor of a fecal transplant affects IBS symptoms. 500 patients with moderate-to-severe IBS will receive either a placebo (their own stool) or stool from one of three different donors, delivered via a tube into the small intestine. They will track symptoms, quality of life, and gut bacteria changes over a year to see if donor selection leads to better outcomes.

What this could mean

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

Active substance
fecal microbiota transplant (FMT) from selected donors
What this could lead to
If successful, this could show that choosing the right donor improves FMT outcomes for IBS, offering a more effective symptom relief option.
What could go wrong
This is a mid-sized trial, but FMT is still experimental for IBS. Results may vary, and long-term benefits or risks are not yet fully known.

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 500 people

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

Started

Feb 2024

Expected to finish

Aug 2028

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 80 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: * Patients who fulfil Rome IV criteria for the diagnosis of IBS. * Patients were investigated to exclude other gastrointestinal organic cause(s). * Moderate-to-severe IBS symptoms, as indicated by a score of ≥175 on the IBS-SSS questionnaire Exclusion Criteria: * Pregnant, women planning pregnancy or lactating women. * The use of antibiotics or probiotics within 1 month prior to FMT. * Having undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy. * Previous treatment with FMT. * Immunocompromised patients including those being treated by immunosuppressive medications. * Patients with co-morbidity such as kidney failure, diabetes or chronic heart disease. * Patients with serious psychiatric disorders or alcohol or drug abuse.

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Conditions

The condition(s) this trial relates to.

Dysbiosis Fatigue 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

  • Diakonhjemmet

    Oslo, Norway

  • Haukeland University Hospital

    Bergen, Vestland, 5021, Norway

  • Helse Møre og Romsdal HF

    Ålesund, Norway

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