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RecruitingPhase 3NCT07458984

FMT Capsules for rCDI

Fecal Microbiota (FMT) Oral Capsules in the Treatment of Recurrent Clostridioides Difficile Infection

Sponsor

Helsinki University Central Hospital

Enrollment

76 participants

Start Date

Apr 25, 2026

Study Type

INTERVENTIONAL

Conditions

FMTClostridioides Difficile Infection Recurrence

Summary

Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • At least twice recurrent CDI*
  • Patient has had CDI-related diarrhea during infections (3 or more Bristol Stool Form Scale type 6-7 stools)
  • Other causes of diarrhea have been excluded based on clinical data
  • Age over 18 years
  • Remission of symptoms during antibiotic course (metronidazole, vancomycin or fidaxomicin)
  • No other antibiotic courses
  • Able to sign the consent form or accept it electronically via Suomi.fi identification
  • definition of recurrent CDI: CDI-compatible symptoms and a positive stool test Clostridioides difficile nucleic acid test within 12 weeks of the previous infection

Exclusion Criteria7

  • Pregnancy
  • Continuous need for antibiotic treatment
  • Previous anaphylactic reactions to any food
  • Gastroparesis
  • Life-threatening fulminant CDI
  • Life expectancy less than 1 year
  • Inability to sign a consent form for the study

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Interventions

BIOLOGICALHealthy donor stool

Healthy donor stool given by capsules produced by the same method as in Copenhagen University Hospital

BIOLOGICALplacebo capsule

Copenhagen University Hvidrovre Hospital method for capsule production

Locations(1)

Helsinki University Hospital

Helsinki, Uusimaa, Finland

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