Actively Recruiting
Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Via Capsules for Intestinal Multidrug-resistant Bacteria Decolonization
Led by University of Rijeka · Updated on 2025-12-18
48
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
Sponsors
U
University of Rijeka
Lead Sponsor
C
Clinical Hospital Center Rijeka
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Via Capsules for Intestinal Multidrug-resistant Bacteria Decolonization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Positive rectal swab for multidrug-resistant organisms (CRE, ESBL-E, VRE) within one week before randomization
- Able to swallow oral capsules
- Willing to provide informed consent
You will not qualify if you...
- Receiving antibiotic treatment on the day of inclusion
- Pregnant, breastfeeding, or women of childbearing potential unwilling or unable to use birth control
- Terminal disease with life expectancy less than 6 months
- Unwilling to ingest capsules
- History of colectomy, current colostomy, or ileostomy
- Diagnosis or treatment of inflammatory or functional bowel disease
- Malignant bowel diseases
- Absolute neutrophil count below 500/mm3
- Selective digestive decolonization with antibiotics within 6 months before randomization
- Severe allergy to capsule components
AI-Screening
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Trial Site Locations
Total: 1 location
1
Clinical Hospital Center Rijeka
Rijeka, Croatia, 51000
Actively Recruiting
Research Team
I
Igor Rubinić, MD
CONTACT
N
Nataša Skočibušić, mag clin nutr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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