Fecal Transplantation to Eradicate Colonizing Emergent Superbugs
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-105
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
Qualifiers
≥ 18 years and < 105 years
Healthy subjects ≥ 18 years and < 50 years
Body mass index < 30 kg/m²
Regular bowel movement defined as at least 1 stool every 2 daysand maximum than 3 stools per day
Disqualifiers
Current antibiotic treatment with te exception of long term antibiotic prophylaxis (duration of at least 3 months/year)
Patients hospitalized in the intensive care unit
Pregnancy or breastfeeding during the study
Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)] to avoid pregnancy for the entire study
Trial design
Treatments tested in this trial
- Fecal Microbiota Transplantation (FMT) capsules
- Placebo capsules
Treatment groups
214 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov