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NCT03029078 Clinical Trial

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

Microbial Colonization Clinical Trial

— FEDEX  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03029078
Other study ID # GIPIT002
Secondary ID 2014-003048-11
Status Completed
Phase Phase 4
First received
Last updated
Start date November 1, 2014
Est. completion date December 1, 2020

Study information
Verified date July 2021
Source Centre d'Investigation Clinique et Technologique 805
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 1, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hopital Raymond Poincaré Garches

Sponsors (1)
Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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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