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

Centre d'Investigation Clinique et Technologique 805

Status and phase: Completed; Phase 4

Conditions: Faeces Smearing; Bacterial Peritonitis; Microbial Colonization

Treatments: Drug: fecal microbiota transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT03029078

GIPIT002

2014-003048-11 (EudraCT Number)

Details and patient eligibility

About

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

Full 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)

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Fecal transplantation

Experimental group

Description:

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.

Treatment:

Drug: fecal microbiota transplant