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Poop pills from different donors: a new hope for ulcerative colitis?

NCT ID NCT06591013

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 01, 2026 · Updated 3 times

Summary

This study tested fecal microbiota transplantation (FMT) from different donors to treat ulcerative colitis, a type of inflammatory bowel disease. Researchers gave 102 patients a one-time colonoscopic infusion of fresh fecal bacteria from healthy donors. The goal was to see if donor differences affect remission rates and gut health, offering a potential new treatment option for those who stop responding to standard therapies.

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 (FMT)
What this could lead to
If successful, this could point toward a more effective, donor-matched FMT approach for managing ulcerative colitis and reducing symptoms.
What could go wrong
This is a completed early-stage study with 102 participants, so results may not apply to everyone. FMT carries risks like infection or worsening of symptoms, and long-term benefits are uncertain.

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

102 people

The number who actually took part.

Started

Oct 2024

Finished

Oct 2025

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

14 to 79 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. Age between 14 and 79 years (inclusive), any gender. 2. Diagnosed with ulcerative colitis (UC) per established clinical, endoscopic, and histological standards, with a disease duration of over 3 months. 3. Active mild-to-moderate UC, defined by a Mayo score of 4-10, including an endoscopic score ≥1 and a physician's global assessment score ≤2. 4. Stable baseline medication consisting of 5-aminosalicylic acid (mesalamine). 5. Signed written informed consent. Exclusion Criteria: 1. Participants unable to provide informed consent, answer questionnaires, or supply samples. 2. Pregnant women or those attempting to conceive. 3. Participants unwilling to use effective contraception throughout the study. 4. Participants deemed in remission by investigators. 5. Evidence or history of toxic megacolon. 6. Isolated rectal inflammation (\<5 cm in extent). 7. Diagnosed with Crohn's disease or indeterminate colitis. 8. Participants with perianal diseases (e.g., fistulae, anal fissures). 9. History of significant gastrointestinal surgery (e.g., colectomy) : * Minor surgeries will be reviewed case by case. * Patients with appendectomy within 3 months will be excluded. 10. Antibiotic use within the past 4 weeks for any reason, including for UC. 11. Steroid dependence requiring \>20 mg prednisone or \>9 mg budesonide daily at enrollment. 12. Recent or anticipated usage of prohibited drugs during the study period, including: * Rectal corticosteroids within 2 weeks prior to the first FMT. * Biologics (e.g., infliximab, adalimumab, vedolizumab) within 4 weeks prior to the first FMT. * Other major immunosuppressants (e.g., calcineurin inhibitors, antitumor drugs) within 12 weeks prior to treatment. * Probiotics within 4 weeks before the first FMT. * Experimental drugs or protocols within 12 weeks before the first FMT. * Anti-tuberculosis (TB or MAC) treatment within 4 weeks before the first FMT. Permitted Medications: Participants may continue using the following medications if doses are stable within specified timeframes before the first FMT: * Oral 5-aminosalicylic acid (stable for 4 weeks). * Azathioprine and methotrexate (≥90 days of use with stable doses for 4 weeks). * Oral prednisone (≤20 mg/day, stable for 2 weeks, gradually tapered at a rate of 2.5 mg/week to discontinue by week 8). Subjects should maintain the same doses of oral 5-aminosalicylates, thiopurines, and methotrexate during the study. For oral prednisolone, the dose had to be tapered off gradually, at a rate of 2.5mg per week, so that subjects were no longer exposed to steroids until week 8. Prohibited Medications: * Rectal corticosteroids (2 weeks before and throughout the study). * Antibiotics, antifungals, antivirals, probiotics, or prebiotics (4 weeks before and throughout the study). * Biologics or calcineurin inhibitors (12 weeks before and throughout the study). Participants using prohibited medications during the study will remain enrolled, and outcomes will still be evaluated. All prohibited medication usage will be recorded.

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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

  • China

    Kunming, Yunnan, 650032, China

More trials for these conditions

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