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Comparison of Three Interventions for Antibiotic-Resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract

NCT07094984 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-09-03

No results posted yet for this study

Summary

The aim of this research experiment is to evaluate the effectiveness of fecal microbiota transplantation (FMT) preceded by antibiotic pre-treatment versus probiotic therapy and a standard-of-care equivalent diet designed to stimulate the growth of eubiotic gut microbiota (an active comparator enhancing the ethical value of the study and increasing the chances of spontaneous decolonization of antibiotic-resistant bacteria (ARB) in the absence of any active intervention recommended by Scientific Societies) in the decolonization of bacteria with the most clinically significant antibiotic resistance mechanisms from the gastrointestinal tract of colonized patients.

This study addresses the urgent need highlighted by the World Health Organization (WHO) for new strategies to combat antibiotic resistance, aiming to prevent its progression into a global pandemic that could undermine the achievements of modern civilization.

Study Hypotheses:

* The decolonization rate of ARB bacteria in patients undergoing the intervention (FMT or probiotic therapy) is the same as in patients treated with standard-of-care (SoC) alone.
* The decolonization rate of ARB bacteria in the intervention groups (FMT or probiotic therapy) is at least 20 percentage points higher than in patients treated with the standard approach (diet).

The findings from this study may contribute to developing innovative microbiota-based therapies for the decolonization of antibiotic-resistant bacteria and help reduce the global burden of antibiotic resistance.

Conditions

  • Drug Resistance, Bacterial
  • Antimicrobial Drug Resistance

Interventions

OTHER

Fecal microbiota transplantation (FMT)

FMT administered after antibiotic pre-treatment and bowel cleansing. Delivered either in capsule form or via colonoscopy to restore healthy gut microbiota and support decolonization of ARB.

DIETARY_SUPPLEMENT

Probiotic Therapy

Oral administration of a high-dose multistrain probiotic containing Lactobacillus, Bifidobacterium, and Streptococcus strains for 20 days following bowel cleansing.

OTHER

Gut Microbiota Boosting Diet

A structured 38-day diet designed to promote eubiosis and support spontaneous ARB decolonization. Meals are tailored and delivered to patients based on clinical nutrition protocols.

Sponsors & Collaborators

  • Human Biome Institute S.A.

    collaborator INDUSTRY

  • Medical Research Agency, Poland

    collaborator OTHER_GOV

  • Medical University of Warsaw

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2027-02-01
Completion
2027-04-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07094984 on ClinicalTrials.gov