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

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Colonization, Asymptomatic

In brief

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

Key facts

Study ID

NCT07106580

Run by

University of Rijeka

People needed

48

Starts

2025-07-28

Expected to finish

2027-09-01

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years,
• stool sample or rectal swab positive for MDRO (CRE, ESBL-E, VRE) within a week of randomization,
• capable of swallowing oral capsules,
• willing to give informed consent

You may not qualify if…

• antibiotic treatment on the day of inclusion,
• pregnant or breastfeeding, women of childbearing potential who are unwilling or unable to use an acceptable method of birth control,
• patients with terminal diseases with expected life expectancy < 6 months,
• unwillingness to ingest the capsules,
• a history of colectomy, present colostomy or ileostomy,
• patients with the diagnosis/treatment of inflammatory or functional bowel disease,
• patients with malignant bowel diseases,
• absolute neutrophil count < 500/mm3,
• selective digestive decolonization with antibiotics within 6 months before randomization,
• severe allergy to capsule components

Where it is running

• Clinical Hospital Center Rijeka — Rijeka, Croatia (enrolling)

Full record on ClinicalTrials.gov

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