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Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection

NCT04885946 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-06-09

No results posted yet for this study

Summary

Clostridioides difficile (CD) infection (CDI) is a global health threat with an urgent need for new treatment strategies. Faecal microbiota transplantation (FMT) is effective for recurrent Clostridioides difficile infection (CDI), and is currently recommended for multiple (three or more), recurrent CDI infections. The role of FMT earlier in the treatment hierarchy of CDI remains to be determined.

In this randomized, double-blinded, placebo-controlled clinical trial, we compare FMT with placebo following standard antibiotic treatment for first or second Clostridioides difficile infection.

Conditions

  • Clostridium Difficile Infection
  • Clostridioides Difficile Infection

Interventions

OTHER

Fecal microbiota transplantion (FMT)

Single donor, fecal microbiota transplantion (FMT) from healthy human donors.

OTHER

Placebo

Food coloring, water, glycerol

Sponsors & Collaborators

  • Innovation Fund Denmark

    collaborator INDIV

  • Christian Hvas

    lead OTHER

Principal Investigators

  • Christian L Hvas, PhD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2022-03-31
Completion
2024-12-31

Countries

  • Denmark

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 NCT04885946 on ClinicalTrials.gov