FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach

NCT06071312 | Recruiting Phase 1

• 1 other identifier: 5183
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile; Ulcerative Colitis

Keywords

Ulcerative Colitis; Clostridium difficile; Fecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

• Number of UC patients who will obtain the eradication of rCDI 8 weeks after treatments (single FMT vs sequential FMT)

  The investigators will compare the number of participants who will obtain the eradication of rCDI (assessed by C. difficile toxin exam) 8 weeks after treatments (single FMT vs sequential FMT)

  2 months

Secondary Outcomes (4)

• Number of UC patients who will obtain the eradication of rCDI 1 - 4 weeks after treatments (single FMT vs sequential FMT)

  1 months

• Evaluation of changes in recipients' microbiome after treatments, at each time point.

  2 months

• Evaluation of Ulcerative Colitis activity

  2 months

• Evaluation of the safety of the two treatments

  2 months

Study Arms (2)

. Single FMT

EXPERIMENTAL

Patients enrolled in this arm will receive a single infusion of donor FMT

Biological: single FMT

Sequential FMT

ACTIVE COMPARATOR

Patients enrolled in this arm will receive sequential infusions of donor FMT

Biological: sequential FMT

Interventions

single FMT BIOLOGICAL

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

. Single FMT

sequential FMT BIOLOGICAL

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

Sequential FMT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Active UC (partial Mayo score ≥2);
• Relapsing infection of C. difficile;
• Indication, in the clinical practice setting, for fecal microbiota transplantation from a healthy donor for recurrent CDI

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Gianluca Ianiro, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluca Ianiro, MD

CONTACT

+39 0630157338; gianluca.ianiro@unicatt.it

Serena Porcari, MD

CONTACT

+39 0630157338; porcariserena89@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, controlled, open-label, single-center trial.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 6, 2023
• Study Start: September 23, 2023
• Primary Completion (Estimated): September 24, 2026
• Study Completion (Estimated): September 24, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data will be available after the completion of the study, for 5 years
• Access Criteria: Data will be given upon request to the PI

Locations

IT (1)