Superdonor FMT in Patients With Ulcerative Colitis
Phase 1 / Phase 2 · Testing FMT · 1 site · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing FMT (a biologic) as a possible treatment. Condition(s) listed: Active Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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;
Plus 2 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 42 participants are expected to take part.
- Start date: 2023-02-13.
- Main results expected around 2027-02-14 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Number of patients who will obtain remission of disease 8 weeks after treatments (2 months)
In the researchers’ words
In the last decades fecal microbiota transplantation (FMT) has been established as a highly effective option in the treatment of recurrent Clostridioides difficile infection (rCDI), with a success rate of nearly 90%. For this reason, it is recommended by international guidelines as a treatment option for this indication in clinical practice.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional |
| Conditions | Active Ulcerative Colitis |
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Enrollment | 42 (estimated) |
| Start date | 2023-02-13 |
| Primary completion (est.) | 2027-02-14 |
| First posted | 2023-02-22 |
| Last updated | 2026-03-19 |
| 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 |
| ClinicalTrials.gov ID | NCT05739864 |
Interventions
- FMT (Biological)
This intervention is represented by the administration, in the recipients' gut, of super - donor microbiota through FMT - Placebo FMT (Other)
This intervention is represented by the administration, in the recipients' gut, of a placebo through FMT
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Gianluca Ianiro | Rome, Lazio | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.