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

NCT07106580 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-18

No results posted yet for this study

Summary

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

Conditions

  • Colonization, Asymptomatic

Interventions

OTHER

lyophilized FMT capsules

A total of 18 capsules containing 3060 mg of lyophilizate given through 3 days (three capsules twice daily)

OTHER

Placebo capsules

18 capsules of identical appearance and weight given in the same way as FMT capsules

Sponsors & Collaborators

  • Clinical Hospital Center Rijeka

    collaborator OTHER

  • University of Rijeka

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Croatia

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 NCT07106580 on ClinicalTrials.gov