Fecal Transplantation to Eradicate Colonizing Emergent Superbugs
Carriage of multi-drug and extensive-drug resistant Gram negative bacteria (MDR-GNB) is associated with an increased risk of infections by these bacteria for the carriers and a high risk of dissemination both in the healthcare setting and the community; the main MDR-GNB reservoir is the fecal microbiota. To prevent bot
| Condition(s) | Enterobacteriaceae Infections, Fecal Microbiota Transplantation |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Carriage of multi-drug and extensive-drug resistant Gram negative bacteria (MDR-GNB) is associated with an increased risk of infections by these bacteria for the carriers and a high risk of dissemination both in the healthcare setting and the community; the main MDR-GNB reservoir is the fecal microbiota. To prevent both infections and dissemination, effective measures to decolonize subjects carrying MDR-GNB are urgently needed. Animal models, case reports and cohort studies suggest fecal microbiota transplantation (FMT) may be efficient for MDR-GNB decolonization. |
| Who can participate | Inclusion Criteria: Inclusion Criteria for patients: * ≥ 18 years and \< 105 years * Patient with at least one positive rectal swab for enterobacteria: extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) or carbapenem-resistant Enterobacteriaceae (CRE), or who have had an ESBL-E or CRE infection within the year For ESBL-E carriers: an ESBL-E infection within the year is mandatory \- Patient able to take 50 capsules orally in a day and without swallowing disorders Inclusion Criteria for healthy volunteers donors: * Healthy subjects ≥ 18 years and \< 50 years * Body mass index \< 30 kg/m\^2 * Regular bowel movement defined as at least 1 stool every 2 daysand maximum than 3 stools per day Exclusion Criteria: Exclusion Criteria for patients: * Current antibiotic treatment with |
| Ages | 18 Years to 105 Years |
| Sex | All |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Locations | Clichy, France; Créteil, France; Garche, France; Le Kremlin-Bicêtre, France; Paris, France; Paris, France (+5 more sites) |
| Start date | 2024-01-11 |
| NCT ID | NCT05035342 |
| Official listing | https://clinicaltrials.gov/study/NCT05035342 |