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

NCT03029078 | Completed Phase 4

• 2 other identifiers: GIPIT0022014-003048-11
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Microbial Colonization; Bacterial Peritonitis; Faeces Smearing

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Metagenomics profile between donor and recipient depending on decolonization

  At one week, 2 weeks, one month up to 3 months

Study Arms (1)

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.

Drug: fecal microbiota transplant

Interventions

fecal microbiota transplant DRUG

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

Also known as: FEDEX

Fecal transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient harboring a VRE or CRE bacteria
• Colonization confirmed by our microbiology department, including at least 3 positives swabs in the last month

You may not qualify if:

• Pregnant woman or breastfeeding
• immunosuppression including AIDS, corticosteroids over 60mg/day
• impossibility to obtain a signed consent form.

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead

Study Sites (1)

Hopital Raymond Poincaré

Garches, 92380, France

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Benjamin Davido, MD, MS

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, M.S

Model Details: 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

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: November 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)