NCT06071312 FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
| NCT ID | NCT06071312 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Clostridium Difficile |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2023-09-23 |
| Primary Completion | 2026-09-24 |
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 64 participants in total. It began in 2023-09-23 with a primary completion date of 2026-09-24.
⚠ 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
Clostridioides difficile infection (CDI) is the most frequent cause of infectious diarrhea in hospitalized patients and is responsible for 20-30 % of antibiotic-associated diarrhea cases. Inflammatory bowel diseases (IBD) are associated with an higher prevalence, recurrence and severity of CDI. The prevalence of recurrent CDI in patients with IBD is 2.5 to 8 times higher than in the general population, with a cumulative lifetime risk of 10 %. The higher risk to the development of CDI in patient with IBD is directly related to the microbiome alterations that are associated with this chronic disoder. Moreover, the use of antibiotics to cure CDI further worsens the gut microbiota, triggering potentially a self-maintaining cycle and predisposes such patients to a higher risk of recurrence. In these patients, CD superinfection is associated, with an increased rate of hospitalization, length of stay, the need to modify the treatment to the underlying disease, the increase rate of colectomy, there higher mortality rate, with a net increase of health costs. Nowadays, as emerged by several studies FMT has been established as a valid treatment option against recurrent CDI (rCDI), and it is recommended by international guidelines. Unfortunately, most FMT studies for rCDI have excluded patients with IBD. Recent evidence suggests that FMT is effective in patients with ulcerative colitis (UC) and concomitant rCDI, both in the treatment of the infection and in the improve of disease activity. To date, most studies evaluated the efficacy of single infusion of FMT in these patients. Preliminary data from our group suggest that a sequential approach (i.e., repeated fecal infusions) may increase the efficacy of FMT in this population. Indeed, in 18 patients with IBD, single infusion fecal resulted in eradication of rCDI in 60% of cases, whereas this outcome was achieved in 89% of cases using a sequential approach. Similar data have been demonstrated in a retrospective study by Fischer and colleagues. However, more studies are advocated to confirm these results. Therefore, our study aim to compare the efficacy of single FMT vs. sequential in the eradication of rCDI in patients with UC.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years; * Active UC (partial Mayo score ≥2); * Relapsing infection of C. difficile; * Ability to express consent for inclusion in the study. * Indication, in the clinical practice setting, for fecal microbiota transplantation from a healthy donor for recurrent CDI Exclusion Criteria: * Age \< 18 years; * Other gastrointestinal infections, excluding C. difficile; * Known gastrointestinal diseases, other than UC, in active stage (e.g., infectious gastroenteritis, celiac disease, irritable bowel syndrome, chronic pancreatitis, bile acid diarrhea, etc.); * Previous colon surgery or skin ostomy packing; * Food allergies; * Current or recent (\<2 weeks) therapy with drugs that may alter the microbiota (e.g., systemic antimicrobials, probiotics, proton pump inhibitors, immunosuppressants, metformin), except antibiotics against C. difficile; * Heart failure or heart disease with FE ≤ 30 %; * Severe respiratory failure; * Psychiatric disorders; * Pregnancy and lactation; * Inability to provide informed consent.
Contact & Investigator
Gianluca Ianiro, MD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06071312 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Clostridium Difficile. 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 NCT06071312 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 NCT06071312 currently recruiting?
Yes, NCT06071312 is actively recruiting participants. Contact the research team at gianluca.ianiro@unicatt.it for enrollment information.
Where is the NCT06071312 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06071312 clinical trial?
NCT06071312 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Gianluca Ianiro, MD at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 64 participants.