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

NCT07106580 | Recruiting Phase 1

• 1 other identifier: 2170-1-42-04-3/1-25-5
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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

Colonization, Asymptomatic

Keywords

FMT; Fecal microbiota transplantation; Colonization; MDRO; Multidrug-resistant bacteria; Lyophilization

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 180 ± 7 from randomization

Secondary Outcomes (2)

• Early decolonization

  Day 30 +/- 3 after randomization

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  From randomization to day 180 +/-7

Study Arms (2)

FMT

EXPERIMENTAL

lyophilized FMT capsules

Other: lyophilized FMT capsules

Placebo

PLACEBO COMPARATOR

Placebo capsules

Other: Placebo capsules

Interventions

lyophilized FMT capsules OTHER

A total of 18 capsules containing 3060 mg of lyophilizate given through 3 days (three capsules twice daily)

FMT

Placebo capsules OTHER

18 capsules of identical appearance and weight given in the same way as FMT capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rijeka: lead
• Clinical Hospital Center Rijeka: collaborator

Study Sites (1)

Clinical Hospital Center Rijeka

Rijeka, 51000, Croatia

RECRUITING

MeSH Terms

Conditions

Asymptomatic Infections

Condition Hierarchy (Ancestors)

Infections; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Igor Rubinić, MD

CONTACT

+38551658513; igor.rubinic@uniri.hr

Nataša Skočibušić, mag clin nutr

CONTACT

+385658513; natasa.skocibusic@kbc-rijeka.hr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal investigator

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 6, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: Data will be shared with qualified researchers for academic purposes under a data use agreement. Requests should be directed via e-mail.

Locations

CR (1)