Fecal Transplantation to Eradicate Colonizing Emergent Superbugs

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 27, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of fecal microbiota transplantation (FMT) to help eliminate certain harmful bacteria known as multi-drug resistant Gram-negative bacteria (MDR-GNB) from the gut. These bacteria can cause serious infections and are often difficult to treat. FMT involves transferring healthy bacteria from a donor's stool to a patient’s gut, which may help restore a healthy balance and reduce the risk of infections. The trial is looking for both patients who are currently carrying these harmful bacteria and healthy volunteers who can donate their stool.

To be eligible for the trial, patients need to be adults aged 18 to 105 who have specific types of resistant bacteria in their system. They must also be able to take oral capsules for two days. Healthy volunteers should be between 18 and 50 years old, have a healthy body weight, and have regular bowel movements. Participants in the trial can expect to take a treatment that involves these capsules and will be monitored for the effectiveness of the procedure. It's important to note that certain individuals, such as those currently on antibiotics or pregnant, cannot participate. This study is crucial in finding new ways to combat these dangerous bacteria and protect both patients and the community.

Gender

ALL

Eligibility criteria

• 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 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
• • Patient under legal protection
• • Participation in another interventional study
• • Non-affiliation to a social security scheme
• • Patient under AME
• • Refusal to participate to the study
• Exclusion Criteria for healthy volunteers donors:
• • Any history of or current proctologic disease or any acute condition, which in the investigator's judgment could harm the volunteer and/or compromise or limit the evaluation of the protocol or data analysis (for details, please see protocol)
• • Subject under legal protection
• • Participation in any other interventional study
• • No-affiliation to a social security scheme
• • Subject under AME
• • Refusal to participate to the study
• Randomization criteria:
• • Patient colonized with a carbapenem-resistant Enterobacteriaceae (CRE) and/or colonized with an extended spectrum β-lactamase producing Enterobacteriaceae (ESBL-E) at inclusion on stool culture
• • Patient with an ESBL-E infection in the previous 12 months (only for participants no colonized with CRE).
• • Compatible transplant (FMT) based on patient's serological profile (CMV/EBV) available