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Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Via Capsules for Intestinal Multidrug-resistant Bacteria Decolonization

Study acronym: FORCE
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified Show 4 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 47 words
    • Publications: details revised at 1 of 1 entry
  2. Primary and study completion dates: Jul 2026 to Sep 2027
    • Secondary endpoints: 2 to 4
    • Eligibility criteria shortened, about 2 words
    v5
  3. Re-verified, no change to tracked fieldsv4
  4. Start date changed from estimate of Aug 2025 to Jul 28, 2025v3
  5. Primary endpoint revisedv2 Show 4 more changesShow less
    • Secondary endpoints revised (2)
    • Study description revised
    • Site contact updated
    • Collaborators expanded, about 4 words
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if oral capsules containing lyophilized stool from healthy donors (fecal microbiota transplantation or FMT) can safely and effectively decolonize multidrug-resistant organisms (MDROs) from the intestines in adults. The main questions it aims to answer are: 1. Does FMT via oral capsules reduce or eliminate intestinal MDRO colonization? 2. What side effects or adverse events occur after taking FMT capsules? Researchers will compare FMT capsules to placebo capsules to see if FMT is effective and safe for decolonizing MDROs. Participants will: * Take either FMT capsules or placebo capsules by mouth * Attend 4 follow-up study visits over 6 months (180 days) for microbiological testing and safety monitoring * Provide stool samples and report any side effects
Trial Details
NCT Number NCT07106580
Lead Sponsor University of Rijeka
Collaborators: Clinical Hospital Center Rijeka
Conditions
(from sponsor)		 Colonization, Asymptomatic
Related terms Asymptomatic Infections
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov