FMT for the Decolonization of Carbapenem-resistant Enterobacteriaceae

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Feb 13, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called fecal microbiota transplantation (FMT) to see if it can help patients who are colonized by a type of bacteria called carbapenem-resistant Enterobacteriaceae (CRE). These bacteria are known for being resistant to many antibiotics, which makes infections difficult to treat. The study aims to determine if receiving FMT from healthy donors can effectively eliminate these bacteria from the gut, compared to a placebo treatment that does not contain live bacteria. Participants will undergo a procedure where the healthy stool is delivered into their intestines through a colonoscopy, and then they will be monitored for about three months to see if the treatment works.

To be eligible for the trial, participants need to be at least 18 years old and have a confirmed diagnosis of gut colonization by CRE. They should also be able to give their consent to join the study. However, individuals with certain gastrointestinal disorders, recent treatments that might affect gut bacteria, or other serious health issues may not qualify. If they do participate, patients can expect regular follow-ups, including tests to check for the presence of CRE in their gut after the treatment. This research is important because it could offer a new way to manage antibiotic-resistant infections, which are a growing concern in healthcare.

Gender

ALL

Eligibility criteria

• • 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