FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae

NCT05791396 | Recruiting Phase 1

• 1 other identifier: 5544
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Antibiotic resistance (AR) is a critical public health threat and one of the greatest challenges of the 21st century. In an estimate of 2019, nearly 700.000 infections and 33.000 attributable deaths from multi-drug-resistant bacteria (MDRB) have occurred in Europe in 2015. The gastrointestinal tract is a large reservoir for MDRB, and the gut microbiota can harbor a collection of AR genes, called gut resistome. Preliminary nonrandomized evidence suggests that fecal microbiota transplant (FMT) could be a promising treatment option to eradicate MDRB, but established evidence, as well as mechanisms that underpin this therapeutic pathway, are still unavailable. Leveraging our expertise in FMT (OU1), microbiome (OU2) and MDRB (OU3), we aim to evaluate the efficacy of FMT (from donors with limited presence of AR genes) in eradicating intestinal MDRB through a randomized controlled trial and identifying microbial features that are associated with clinical efficacy and clearance of AR genes

Conditions

Enterobacteriaceae Infections; Multi-antibiotic Resistance

Keywords

Fecal microbiota transplantation; Enterobacteriaceae; Multi-drug resistant bacteria

Outcome Measures

Primary Outcomes (1)

• CRE eradication at week 4 after the end of treatments

  The investigators will evaluate the number of participants who will obtain eradication of CRE carriage after treatments, at 4 weeks-follow-up, evaluated through rectal swab for CRE

  4 weeks

Secondary Outcomes (2)

• CRE eradication at week 1 and 12 after the end of treatments

  12 weeks

• microbiome changes after treatments

  12 weeks

Study Arms (2)

Donor FMT

EXPERIMENTAL

Patients enrolled in this arm will receive donor FMT

Biological: Donor - FMT

Placebo FMT

PLACEBO COMPARATOR

Patients enrolled in this arm will receive placebo FMT (that will be made of water)

Other: Placebo FMT

Interventions

Donor - FMT BIOLOGICAL

this intervention is represented by the administration, in the recipients' gut, of donor microbiota through FMT

Donor FMT

Placebo FMT OTHER

This intervention is represented by the administration, in the recipients' gut, of a placebo through colonoscopy

Placebo FMT

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years;
• CRE diagnosed with rectal swab \<15 days before evaluation;
• Ability to undergo study procedures and to give informed consent.

You may not qualify if:

• Active chronic gastrointestinal disorders;
• Previous colorectal surgery;
• Major comorbidities;
• Pregnancy/breastfeeding;
• Psychiatric disorders.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Giovanni Cammarota

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Enterobacteriaceae Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To mask treatments to physicisans and recipients, both FMT bottles and syringes will be covered with dark-coloured paper before the infusion, and the patients will be unable to see the endoscopic display during the procedure. Moreover, the physicians who will evaluate patients at follow-up will not aware of the treatment being administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 30, 2023
• Study Start: February 8, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

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 reasonable request to the PI

Locations

IT (1)