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Recruiting NCT07458984

FMT Capsules for rCDI

Phase III Interventional Clostridioides Difficile Infection Recurrence FMT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Healthy donor stool, placebo capsule.
Who it may be relevant to
Registry conditions: Clostridioides Difficile Infection Recurrence, FMT. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

The aim of the study is to investigate the efficacy and safety of fecal capsules in the treatment of recurrent Clostridioides difficile infection in a double-blind RCT. The study will also investigate whether stool antigen testing or accurate clinical information on risk factors can identify patients who would benefit most from fecal transplantation. The study will include 76 patients who have had recurrent Clostridioides difficile infection.

Interventions

  • Biological Healthy donor stool
    Healthy donor stool given by capsules produced by the same method as in Copenhagen University Hospital
  • Biological placebo capsule
    Copenhagen University Hvidrovre Hospital method for capsule production

Primary outcome measures

  • Number of patients with recurrence of Clostridioides difficile infection (rCDI), defined as positive fecal Clostridioides difficile nucleinic acid measurement and diarrhea after Fecal Microbiota transplantation (FMT) within 12 weeks after FMT. [Time frame: The investigators evaluate the number of patietns who get rCDI within 12 weeks after FMT (Placebo or active FMT).]
Secondary outcome measures (1)
  • Number of patients with side effects after FMT capsules. [Time frame: One, four and twelve weeks after FMT (placebo or active FMT).]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Finland · 1 center
  • Helsinki University Hospital — Helsinki

Identifiers

NCT: NCT07458984 · 00290 · TYH2025304

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗