Fecal microbiota transplantation using superdonors for ulcerative colitis
Official title: Evaluation of the Efficacy of Superdonor Fecal Microbiota Transplantation in Patients With Mild-to-moderate Ulcerative Colitis: a Double-blind Randomized Controlled Trial
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05739864 · Data updated 2026-11-12
This study is testing whether fecal transplants from specially selected donors can help people with active ulcerative colitis feel better compared to those who receive a placebo.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Status | Recruiting |
| Started | February 13, 2023 |
| Main results expected | February 14, 2027 |
| Study ends | February 14, 2027 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT05739864 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with a recent diagnosis of mild to moderate ulcerative colitis.
✕Probably not a fit
Patients with active gastrointestinal disorders or those who have undergone recent therapies that alter gut microbiota may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of fecal microbiota transplantation (FMT) from superdonors in treating patients with active ulcerative colitis. The study aims to compare the clinical and endoscopic remission rates in patients receiving FMT versus those receiving a placebo. Participants will be closely monitored for their response to treatment, with a focus on the impact of donor selection on outcomes. The trial includes patients aged 18 to 75 with mild to moderate ulcerative colitis who have been stable on maintenance therapies.
Why it matters
Potential benefit: If successful, this approach could significantly improve remission rates in patients with ulcerative colitis.
How similar studies have gone: Previous studies have shown promising results with fecal microbiota transplantation in ulcerative colitis, particularly with the use of superdonors, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 75 years old * Mild to Moderate Ulcerative Colitis (total Mayo score 3 -10 + endoscopic subscore ≥ 1) in stable maintenance therapies (\> 4 weeks with Aminosalicylates, \> 6 weeks with immunosuppressant or biologics agents); * Recent diagnosis (\< 12 months) of Ulcerative Colitis; * Ability to provide written informed consent * Ability to be compliant with the scheduled procedures Exclusion Criteria: * Age \< 18 years old * Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, Crohn disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea) * Previous colorectal surgery or cutaneous stoma * Current or recent (\< 2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics, proton pump inhibitors or metformin) * Decompensated heart failure or heart disease with ejection fraction lower than 30% * Severe respiratory insufficiency * Psychiatric disorders * Pregnancy or breastfeeding * Unable to give informed consent
Where it's running
-
Gianluca Ianiro
Rome, Lazio, Italy Recruiting
Study contacts
- Principal investigator: Gianluca Ianiro — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Gianluca Ianiro, MD
- Email: gianluca.ianiro@unicatt.it
- Phone: +39 0630157338
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.