Faecal Microbiota Transplantation to Eradicate Gut Colonisation From Carbapenem-resistant Enterobacteriaceae: a Randomised Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Rates of antimicrobial resistance are increasing worldwide. There is increasing evidence that physiological gut microbiota is a large reservoir of antibiotic-resistance genes. Healthy gut microbiota is known to prevent the colonization of the gastrointestinal tract by pathogens, the so-called mechanism of colonization resistance, but this protective mechanism can be altered by therapies that impair gut microbiota, including antibiotics or chemotherapeutics, with consequent colonisation of gut pathogens, including multi-drug resistant bacteria (MDRB). MDRB carriers represent an epidemiological threat to other hospitalized patients and to the whole community, but are also at risk of developing clinical consequences of this colonization, including bloodstream infections from these pathogens. Fecal microbiota transplantation (FMT) has shown high efficacy in the eradication of recurrent C. difficile infection, and initial evidence suggests that this procedure could be useful in eradicating also MDRB, mainly carbapenem-resistant Enterobacteriaceae. However, current evidence is mostly limited to case reports and case series, and to a single randomised trial, which was stopped early and did not draw clear conclusion. In a systematic review of 21 studies and 192 patients, eradication rates ranged from 0% to 100%, and authors concluded that larger, well designed randomised controlled trials are needed to further explore this therapy. The aim of this study is to investigate the efficacy of FMT, compared with placebo FMT, in eradicating gut colonisation from MDRB, focusing on CRE. The investigators will randomize patients colonized by CRE (diagnosed by rectal swab) to FMT from healthy donors or placebo, by colonoscopy. Then, patients will be followed up, rectal swabs will be repeated, and stool samples for culture and microbiome analysis will be collected, up to 3 months after FMT.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 18 years old or older

• Current evidence of gut colonisation (diagnosed with rectal swab) by CRE

• Ability to give their consent to be included in the study.

Locations
Other Locations
Italy
Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS
RECRUITING
Rome
Contact Information
Primary
Gianluca Ianiro
gianluca.ianiro@hotmail.it
3381929859
Backup
Serena Porcari
porcariserena89@gmail.com
Time Frame
Start Date: 2021-02-18
Estimated Completion Date: 2026-08-15
Participants
Target number of participants: 52
Treatments
Experimental: Donor FMT
Patients enrolled in this arm will receive donor FMT
Placebo_comparator: Placebo FMT
Patients enrolled in this arm will receive placebo FMT (that will be made of water)
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov