NCT05739864 Superdonor FMT in Patients With Ulcerative Colitis
| NCT ID | NCT05739864 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Active Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2023-02-13 |
| Primary Completion | 2027-02-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2023-02-13 with a primary completion date of 2027-02-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Recently, a considerable body of evidences, suggest FMT as an effective and safe treatment in patients affected by Ulcerative Colitis (UC). In a recent meta-analysis of 324 subjects with UC, 30.4% of patients achieved both clinical and endoscopic remission after FMT compared to placebo (9.8%, P\<0.00001). However, among the various published trials there is a fair variability in terms of methods and results, which are not comparable to those obtained in the rCDI. Nowadays, one of the most critical factors involved in the effectiveness of FMT in UC patients, is the choice of the donor. In addition, several studies have shown that some donors are associated with a higher clinical response rate than others. This hypothesis has been demonstrated in patients affected by irritable bowel syndrome, in which the use of a super-donor (a healthy person who has the predictive clinical and lifestyle characteristics of a healthy microbiota, and with a microbial profile associated with favorable clinical conditions) resulted in significantly higher clinical efficacy rates than placebo, similar to those obtained in rCDI (89%). Currently, studies that explored the efficacy of the super-donor FMT in UC patients are not yet available. Aim of this study is to investigate the efficacy of super - donor FMT, compared with placebo FMT, in the treatment of UC. The investigators will randomize adult patients with a recent diagnosis of UC to FMT from super - donors or placebo, by colonoscopy (first infusion) and capsules administration. Then, patients will be followed up 2 months after FMT.
Eligibility 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
Contact & Investigator
Gianluca Ianiro
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT05739864 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Active Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05739864 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05739864 currently recruiting?
Yes, NCT05739864 is actively recruiting participants. Contact the research team at gianluca.ianiro@unicatt.it for enrollment information.
Where is the NCT05739864 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05739864 clinical trial?
NCT05739864 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Gianluca Ianiro at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 42 participants.
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