FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?

Phase 4

Completed

• Conditions: Microbial Colonization; Bacterial Peritonitis; Faeces Smearing
• Interventions: Drug: fecal microbiota transplant

• Registration Number: NCT03029078
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

Brief Summary

Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug Resistant (XDR) bacteria by performing a fecal transplantation.

Detailed Description

Main objective:

Evaluate the eradication of the colonization of patient harboring XDR bacteria after a fecal transplantation from a healthy donor.

Secondary objectives:

English Evaluate the side effects of this procedure and tolerability. Evaluate the efficacy of the transplant if the patient is harboring glycopeptid resistant enteroccus (GRE) or carbapenem resistant enterobacteriae (CRE)

Study Timeline

• Study Start: 2014-11-01
• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-20
• Study First Posted: 2017-01-24
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patient harboring a VRE or CRE bacteria
• Colonization confirmed by our microbiology department, including at least 3 positives swabs in the last month

Exclusion Criteria

• Pregnant woman or breastfeeding
• immunosuppression including AIDS, corticosteroids over 60mg/day
• ongoing antibiotic treatment at the day of inclusion
• impossibility to obtain a signed consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fecal transplantation	fecal microbiota transplant	Patient will be transplanted with a healthy donor microbiota, free from XDR bacteria, in order to evaluate the impact on the digestive tract colonization Whole process of feces screening and reconstitution was under the responsibility of the pharmacists in charge of the study. Patient will benefit of a naso-duodenal tube in order to perform a bowel lavage prio to the fecal microbiota transplant. Patient will be monitored for 24h to rule out potential adverse events.

Primary Outcome Measures

Name	Time	Method
Negativation of digestive tract colonization	At one week, 2 weeks, one month up to 6 months	Negativation of the rectal swab performed, free from CRE or GRE

Secondary Outcome Measures

Name	Time	Method
Metagenomics profile between donor and recipient depending on decolonization	At one week, 2 weeks, one month up to 3 months	Study with a universal super donor in order to improve efficacy

Trial Locations

Locations (1)

Hopital Raymond Poincaré; 🇫🇷 Garches, France