Status:
RECRUITING
FMT for the Decolonization of Carbapenem-resistant Enterobacteriaceae
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Enterobacteriaceae Infections
Multi-antibiotic Resistance
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
PHASE2
Brief 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 i...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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.
- Exclusion criteria
- Another known gastrointestinal infection apart from C. difficile infection
- Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea)
- Previous colorectal surgery or cutaneous stoma
- Food allergies
- Current or recent (\<2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics, proton pump inhibitors, immunosuppressants, metformin)
- Decompensated heart failure or heart disease with ejection fraction lower than 30%
- Severe respiratory insufficiency
- Psychiatric disorders
- Pregnancy
- Unable to give informed consent
Exclusion
Key Trial Info
Start Date :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2026
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04759001
Start Date
February 18 2021
End Date
August 15 2026
Last Update
March 11 2025
Active Locations (1)
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1
Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS
Rome, Italy, 00168