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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-01

Study Completion Date

2020-12-01

Brief Summary

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

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Detailed Description

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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)

Conditions

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Microbial Colonization Bacterial Peritonitis Faeces Smearing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

fecal microbiota transplant

Intervention Type DRUG

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

Interventions

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fecal microbiota transplant

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

Intervention Type DRUG

Other Intervention Names

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FEDEX

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No