FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria? (FEDEX)
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|ClinicalTrials.gov Identifier: NCT03029078|
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Microbial Colonization Bacterial Peritonitis Faeces Smearing||Drug: fecal microbiota transplant||Phase 4|
Evaluate the eradication of the colonization of patient harboring XDR bacteria after a fecal transplantation from a healthy donor.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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 colonization|
|Masking:||None (Open Label)|
|Official Title:||FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?|
|Actual Study Start Date :||November 1, 2014|
|Estimated Primary Completion Date :||January 1, 2024|
|Estimated Study Completion Date :||January 1, 2024|
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 Name: FEDEX
- Negativation of digestive tract colonization [ Time Frame: At one week, 2 weeks, one month up to 6 months ]Negativation of the rectal swab performed, free from CRE or GRE
- Metagenomics profile between donor and recipient depending on decolonization [ Time Frame: At one week, 2 weeks, one month up to 3 months ]Study with a universal super donor in order to improve efficacy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029078
|Contact: Benjamin Davido, MD, MSfirstname.lastname@example.org|
|Contact: Aurélien Dinh, MDemail@example.com|
|Hopital Raymond Poincaré||Recruiting|
|Garches, France, 92380|
|Contact: Benjamin Davido, MD; MS +33147107758 firstname.lastname@example.org|
|Principal Investigator:||Benjamin Davido, MD, MS||Assistance Publique - Hôpitaux de Paris|