UnknownNot Applicable

Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection

Denmark42 participantsStarted 2021-06-02

Plain-language 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.

Who can participate

Age range18 Years – 130 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\. or 2. CDI (within a year) defined as: \> 3 bowel movements of Bristol 6-7 per day and positive stool CD-test. * Age 18 years or higher. Exclusion Criteria: * Pregnancy * Does not speak or understand the Danish language * Current antibiotic treatment other than vancomycin * Current treatment with potential interations with vancomycin * Allergy to vancomycin * Previous anaphylactic reactions due to food allergies * Continuous need for proton pump inhibitor * Documented gastroparesis * Fulminant CDI

What they're measuring

Resolution of CD-associated diarrhea (CDAD) week 8

Timeframe: 8 weeks following treatment

Mortality week 8

Timeframe: 8 weeks following treatment

Trial details

NCT IDNCT04885946

SponsorChristian Hvas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-31

View on ClinicalTrials.gov More Clostridium Difficile Infection trials