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

Sponsor

Centre d'Investigation Clinique et Technologique 805 (Other)

Overall Status

Completed

CT.gov ID

NCT03029078

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Microbial Colonization Bacterial Peritonitis Faeces Smearing	Drug: fecal microbiota transplant	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pilot study of patients colonized by either CRE or GRE will be enrolled in order to evaluate the impact of fecal microbiota transplant on the eradication of XDR bacteria colonizationPilot study of patients colonized by either CRE or GRE will be enrolled in order to evaluate the impact of fecal microbiota transplant on the eradication of XDR bacteria colonization

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fecal transplantation 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.	Drug: fecal microbiota transplant We will perform a fecal microbiota transplant for patients harboring XDR bacteria in their digestive tract Other Names: FEDEX

Arm

Intervention/Treatment

Experimental: Fecal transplantation

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.

Drug: fecal microbiota transplant

We will perform a fecal microbiota transplant for patients harboring XDR bacteria in their digestive tract

Other Names:

FEDEX

Outcome Measures

Primary Outcome Measures

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

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