A Phase 4 interventional study of fecal microbiota transplant in Microbial Colonization, Bacterial Peritonitis and Faeces Smearing, sponsored by Centre d'Investigation Clinique et Technologique 805. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-27.
Sponsored by Centre d'Investigation Clinique et Technologique 805 · Phase 4, Interventional, and Treatment
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)
185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.
This study's planned enrollment of 50 is below the median of 95 across 118 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →Centre d'Investigation Clinique et Technologique 805 is the lead sponsor of 74 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
We will perform a fecal microbiota transplant for patients harboring XDR bacteria in their digestive tract
Also known as: FEDEX
Negativation of digestive tract colonization
Negativation of the rectal swab performed, free from CRE or GRE
Time frame: At one week, 2 weeks, one month up to 6 months
Metagenomics profile between donor and recipient depending on decolonization
Study with a universal super donor in order to improve efficacy
Time frame: At one week, 2 weeks, one month up to 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Centre d'Investigation Clinique et Technologique 805