RecruitingPhase 1Phase 2NCT06071312

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

64 participants

Start Date

Sep 23, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches for fecal microbiota transplant (FMT) — a procedure where gut bacteria from a healthy donor are transferred to a patient — for people who have both recurrent C. difficile infection (a stubborn gut infection) and ulcerative colitis (an inflammatory bowel disease). Researchers want to know if a single FMT session works as well as several sessions. **You may be eligible if...** - You are 18 or older - You have active ulcerative colitis - You have a recurring C. difficile gut infection - You have been recommended for FMT by your care team - You are able to give informed consent **You may NOT be eligible if...** - You have another active gut infection (other than C. difficile) - You have other active gastrointestinal diseases (like celiac disease or chronic pancreatitis) - You have had FMT before - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALsingle FMT

This intervention is represented by the administration, in the recipients' gut, of healthy donor microbiota through a single infusion of FMT

BIOLOGICALsequential FMT

This intervention is represented by the administration, in the recipients' gut, of healthy donor microbiota through multiple infusions of FMT (sequential approach)


Locations(1)

Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS

Rome, Italy

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NCT06071312


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