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NCT07094984: STOP-ARB3
Comparison of Three Interventions for Antibiotic-Resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract
NA trial testing Fecal microbiota transplantation (FMT) in Drug Resistance, Bacterial in 360 participants. Currently enrolling.
1 February 2027
Quick facts
| Lead sponsor | Medical University of Warsaw |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 360 |
| Start date | 31 December 2024 |
| Primary completion | 1 February 2027 |
| Estimated completion | 30 April 2027 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Fecal microbiota transplantation (FMT) — full drug profile →
- Probiotic Therapy
- Gut Microbiota Boosting Diet
Conditions studied
- Drug Resistance, Bacterial — all drugs for Drug Resistance, Bacterial →
- Antimicrobial Drug Resistance — all drugs for Antimicrobial Drug Resistance →
Sponsor
Medical University of Warsaw
Who can join
18 and older, any sex, with Drug Resistance, Bacterial or Antimicrobial Drug Resistance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07094984
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07094984 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Warsaw
- Last refreshed: 3 September 2025
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