Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Via Capsules for Intestinal Multidrug-resistant Bacteria Decolonization
NCT ID: NCT07106580
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2025-07-28
2026-07-31
Brief Summary
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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
Detailed Description
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Current approaches to MDRO decolonization, including selective digestive decontamination and antimicrobial therapy, have shown inconsistent efficacy and carry the risk of further promoting resistance. Therefore, there is an urgent need for novel, non-antibiotic interventions that can effectively reduce intestinal MDRO colonization.
Fecal microbiota transplantation (FMT) has emerged as a promising strategy to restore a healthy gut microbiome and outcompete resistant organisms. While FMT is an established therapy for recurrent Clostridioides difficile infection, its use in MDRO decolonization remains investigational. Most available data come from small cohort studies or case series, with limited evidence from controlled trials.
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of FMT using lyophilized stool capsules for the decolonization of intestinal MDROs.
Study Design and Intervention
Participants will be randomly assigned (1:1) to receive either:
* Intervention arm: Oral FMT capsules containing lyophilized fecal microbiota from healthy screened donors
* Control arm: Oral placebo capsules identical in appearance but containing an inert substance Both participants and investigators will be blinded to the allocation. The capsules will be administered under supervision, and the total number of capsules and dosing schedule will be consistent with existing FMT protocols for recurrent C. difficile infection, adapted as needed for study-specific safety and feasibility.
The study will include 48 adult participants (≥18 years) who have laboratory-confirmed intestinal colonization with one or more MDROs (e.g., ESBL-E, CRE, or VRE). Colonization must be confirmed by at least one positive stool or rectal swab culture within a defined timeframe prior to randomization.
Study Procedures and Timeline
Participants will be monitored over a 180-day follow-up period, including four follow-up study visits:
Screening/Baseline/Intervention (visit 1-3): Informed consent, screening, confirmation of MDRO colonization, baseline characteristics, randomization. The intervention can be started on the same day.
Follow-up consists of several visits: Visit 4 (Day 7±1), 5 (Day 30±3), 6 (Day 90±3), and 7 (Day 180±7). At each visit, stool samples or rectal swabs will be collected for MDRO culture and participants will be assessed for adverse events, new infections, antibiotic use or changes in health status.
Primary and Secondary Objectives Primary objective: To evaluate the efficacy of oral FMT capsules in decolonizing intestinal MDROs at 180 days post-treatment, measured by the absence of target MDROs in stool cultures.
Secondary objectives: To assess the persistence of decolonization at follow-up visits. To evaluate the safety and tolerability of FMT capsules, including the incidence and severity of adverse events. To evaluate the rate of early decolonization (day 30).
Safety Monitoring All participants will be monitored for adverse events, including gastrointestinal symptoms, infections, allergic reactions, and other unexpected events. Any serious adverse events (SAEs) will be reported to the relevant ethics committee and regulatory authorities in accordance with local and international guidelines.
Potential Impact This trial addresses a critical unmet need in infectious disease management and antimicrobial stewardship. If successful, oral FMT capsules could become a scalable, non-antibiotic approach to MDRO decolonization, with important implications for preventing infections, limiting MDRO spread, and reducing the use of broad-spectrum antimicrobials in high-risk populations. Furthermore, the capsule-based delivery offers a patient-friendly, less invasive alternative to colonoscopic or enema-based FMT administration, potentially improving acceptability and adherence.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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FMT
lyophilized FMT capsules
lyophilized FMT capsules
A total of 18 capsules containing 3060 mg of lyophilizate given through 3 days (three capsules twice daily)
Placebo
Placebo capsules
Placebo capsules
18 capsules of identical appearance and weight given in the same way as FMT capsules
Interventions
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lyophilized FMT capsules
A total of 18 capsules containing 3060 mg of lyophilizate given through 3 days (three capsules twice daily)
Placebo capsules
18 capsules of identical appearance and weight given in the same way as FMT capsules
Eligibility Criteria
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Inclusion Criteria
* rectal swab positive for MDRO (including but not limited to: CRE, ESBL-E, VRE) within a week of randomization,
* capable of swallowing oral capsules,
* willing to give informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Clinical Hospital Center Rijeka
OTHER
University of Rijeka
OTHER
Responsible Party
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Igor Rubinić
Prinicpal investigator
Locations
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Clinical Hospital Center Rijeka
Rijeka, , Croatia
Countries
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Central Contacts
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Facility Contacts
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Nataša Skočibušić, mag clin nutr
Role: primary
Other Identifiers
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2170-1-42-04-3/1-25-5
Identifier Type: -
Identifier Source: org_study_id