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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003048-11 | EudraCT Number |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal transplantation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fecal microbiota transplant | Drug | We will perform a fecal microbiota transplant for patients harboring XDR bacteria in their digestive tract |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Davido, MD, MS | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Raymond Poincaré | Garches | 92380 | France |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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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
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