Oral freeze-dried donor stool capsules to clear antibiotic-resistant gut bacteria.
Official title: A Monocentric, Prospective, Randomized, Placebo-controlled, Double-blinded Trial Investigating the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Capsules in Decolonization of Patients With Intestinal Carriage of Multidrug-resistant Organisms
Run by University of Rijeka · NCT07106580 · Data updated 2026-11-12
This will see if taking oral capsules of freeze-dried healthy donor stool can safely clear multidrug-resistant bacteria from the gut of adults who are colonized.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | University of Rijeka Academic / other |
| Locations | 1 site (Rijeka) |
| Status | Recruiting |
| Started | July 28, 2025 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07106580 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with a recent rectal swab positive for MDRO who can swallow capsules, are not pregnant, and meet safety criteria such as adequate blood counts are ideal candidates.
✕Probably not a fit
People currently on antibiotics, pregnant or breastfeeding women, those with recent colectomy, active inflammatory or malignant bowel disease, or very low neutrophil counts are unlikely to qualify or receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind, placebo-controlled Phase 1/2 trial gives adults with rectal swab–confirmed intestinal colonization by multidrug-resistant organisms either oral capsules of lyophilized fecal microbiota from healthy donors or matching placebo. Participants swallow the assigned capsules and return for four follow-up visits over six months for stool and rectal swab sampling and safety monitoring. The study's main outcomes are reduction or elimination of MDRO colonization in the gut and the type and frequency of adverse events. Microbiological testing of collected samples will be used to determine decolonization over time.
Why it matters
Potential benefit: If successful, this approach could lower gut carriage of MDROs and reduce the risk of subsequent infections and onward transmission.
How similar studies have gone: Small case series and cohort studies have suggested FMT can decolonize MDROs, but high-quality randomized placebo-controlled evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 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 Exclusion Criteria: * 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's running
-
Clinical Hospital Center Rijeka
Rijeka, Croatia Recruiting
Study contacts
- Study coordinator: Igor Rubinić, MD
- Email: igor.rubinic@uniri.hr
- Phone: +38551658513
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.