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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03029078

Acronym

FEDEX

Enrollment

Registered

2017-01-24

Start date

2014-11-01

Completion date

2020-12-01

Last updated

2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Peritonitis, Faeces Smearing, Microbial Colonization

Keywords

XDR, fecal microbiota transplant, eradicate, colonization, CRE, GRE, bacteria

Brief summary

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

Detailed 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)

Interventions

DRUGfecal microbiota transplant

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention 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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026