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

July 26, 2021 updated by: Benjamin DAVIDO, Centre d'Investigation Clinique et Technologique 805
Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug Resistant (XDR) bacteria by performing a fecal transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Hôpital Raymond Poincaré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fecal transplantation

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
Other Names:
  • FEDEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negativation of digestive tract colonization
Time Frame: At one week, 2 weeks, one month up to 6 months
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
Time Frame: At one week, 2 weeks, one month up to 3 months
Study with a universal super donor in order to improve efficacy
At one week, 2 weeks, one month up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Investigation Clinique et Technologique 805

Investigators

  • Principal Investigator: Benjamin Davido, MD, MS, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

January 20, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (Estimate)

January 24, 2017

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIPIT002
  • 2014-003048-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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