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

Study Overview
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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.

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)

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

Conditions
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Microbial Colonization, Bacterial Peritonitis, Faeces Smearing

Intervention / Treatment
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* Drug: fecal microbiota transplant


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal transplantation<br>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<br>* We will perform a fecal microbiota transplant for patients harboring XDR bacteria in their digestive tract<br>* Other names: FEDEX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negativation of digestive tract colonization | Negativation of the rectal swab performed, free from CRE or GRE | At one week, 2 weeks, one month up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metagenomics profile between donor and recipient depending on decolonization | Study with a universal super donor in order to improve efficacy | At one week, 2 weeks, one month up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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XDR, fecal microbiota transplant, eradicate, colonization, CRE, GRE, bacteria