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
≥ 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
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,
Parallel
lyophilized FMT capsules
Other interventionA total of 18 capsules containing 3060 mg of lyophilizate given through 3 days (three capsules twice daily)
Placebo capsules
Other intervention18 capsules of identical appearance and weight given in the same way as FMT capsules
Efficacy (decolonization on visit 7)
Decolonization on day 180 as determined by microbiological analysis. Rectal swabs or stool samples will be collected during each of the scheduled visits. Stool samples are preferred and are self-collected by participants. If stool sample is unavailable, a rectal swab will be collected. The samples will be promptly delivered to the local microbiology laboratory and processed using standard laboratory procedures.
Early decolonization
The proportion of subjects not carrying MDRO at 30 days after randomization as determined by rectal swab or stool sample culture.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
At each study visit, participants will be questioned about adverse events they have experienced since the last study visit. Adverse events are any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. In the absence of reported events, participants will specifically be questioned about common symptoms such as abdominal pain, constipation, nausea, flatulence, vomiting, and febrile episodes.
Time to decolonization
Time from randomisation to first microbiological sample demonstrating absence of MDRO
Incidence of MDRO-related infections
Clinically diagnosed infections caused by the baseline MDRO, confirmed by microbiology and clinical documentation
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University of Rijeka
Lead sponsor
Clinical Hospital Center Rijeka
Collaborator
