NCT06071312RecruitingPhase 1/2
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
Fecal Microbiota Transplantation in Patients With Recurrent Clostridioides Cifficile Infection and Ulcerative Colitis: Single Infusion Versus Sequential Approach
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 3 Oct 2023
- Start date
- 23 Sept 2023
- Primary completion date
- 24 Sept 2026
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Ulcerative colitis
- NCT number
- NCT06071312
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 64
- From 23 Sept 2023 to the primary completion date, 24 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous colon surgery or skin ostomy packing;
- 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;
Other illness
- 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.);
- Food allergies;
- Heart failure or heart disease with FE ≤ 30 %;
- Severe respiratory failure;
- Psychiatric disorders;
Age
- Age \< 18 years;
Other
- Pregnancy and lactation;
- Inability to provide informed consent.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.