Poop pills from different donors: a new hope for ulcerative colitis?
NCT ID NCT06591013
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
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102 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Oct 2025
- Lead sponsor
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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
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14 to 79 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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China
Kunming, Yunnan, 650032, China
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Other studies related to the condition(s) this trial covers.
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