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Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)

NCT04188743 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-09-19

No results posted yet for this study

Summary

Colonization by Multiple Drug Resistant Organisms (MDROs) during patient hospitalization requires expensive isolation measures and renders the return or transfer to other departments or institutions often impossible. Currently there is no specific treatment available. Patients have to wait for spontaneous clearance which can take months or does not happen at all.

The study will test the effect of Fecal Microbiota Transfer (FMT) on gut MDRO colonization. The focus will be on patients with a long-term colonization by Gram-negative bacteria for which isolation is warranted. Participants will be randomized into two treatment groups; allogenic FMT versus autologous FMT. A third group of participants will be monitored but will not receive an FMT. Decolonization rate will be compared one month after treatment. Additionally gut microbial composition will be studied up to one year after FMT.

Conditions

  • Resistance Bacterial

Interventions

BIOLOGICAL

Allogenic FMT

Transplantation of fecal microbiota from a donor into a recipient

BIOLOGICAL

Autologous FMT

Transplantation of autologous fecal microbiota

Sponsors & Collaborators

  • Research Foundation Flanders

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Bruno Verhasselt, Prof. Dr. · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-18
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188743 on ClinicalTrials.gov