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Can a stool transplant calm an inflamed pouch?

NCT ID NCT03545386

Disease control Sponsor: McMaster University 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study tests whether giving healthy donor stool through an enema once a week for six weeks can help people with active pouchitis—a condition where the surgically created intestinal pouch becomes inflamed. Half the participants receive the real transplant, while the other half get a placebo enema. The goal is to see if the treatment can reduce symptoms and inflammation enough to achieve remission.

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 transplantation (donor stool given as an enema)
What this could lead to
If it works, this could offer a new, non-drug way to calm pouchitis and help people avoid long-term antibiotics or surgery.
What could go wrong
This is a small, early-stage trial, so results may not hold up in larger groups. The enema procedure may be uncomfortable, and there is a small risk of infection from donor stool.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

47 people

The number who actually took part.

Started

Apr 2019

Finished

Mar 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 99 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: 1. Patients aged 18 or over 2. Active pouchitis defined as PDAI of 7-18 points 3. Females of child bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance Exclusion Criteria: 1. Participating in another clinical trial 2. Unable to give informed consent 3. Severe comorbid medical illness 4. Concomitant Clostridium difficile infection

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Conditions

The condition(s) this trial relates to.

pouchitis

As listed by the trial registrant

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

Pouchitis

Contacts and locations

Locations

  • McMaster University

    Hamilton, Ontario, L8S4K1, Canada

More trials for these conditions

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