NCT07094984

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

Multicenter, Randomized, Open-label, Three-arm Study on the Efficacy of Fecal Microbiota Transplantation vs Probiotic Therapy vs Eubiotic-gut-microbiota-boosting Diet in Order to Antibiotic-resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract of Patients Colonized With Clinically Most Significant ARBs. Looking for a Strategy to Overcome the WHO Alarm on the Antibiotic Resistance "New Pandemic" Threat. STOP-ARB Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aim of this research experiment is to evaluate the effectiveness of three interventions for decolonization of antibiotic-resistant bacteria (ARB) from the gastrointestinal tract of colonized patients. The interventions include fecal microbiota transplantation (FMT), multistrain probiotic therapy preceded by antibiotic pre-treatment and bowel cleansing, and an eubiotic gut microbiota boosting diet as an active comparator. This approach addresses the urgent global need to develop new strategies against antimicrobial resistance, a growing threat predicted to cause millions of deaths annually by 2050 and significant economic impact. This is an open-label, randomized, controlled experiment with a 2:1:1 allocation ratio (FMT:probiotic:diet). The total planned recruitment is approximately 360 adult patients documented to be colonized with clinically significant antibiotic-resistant bacterial strains, including carbapenem-resistant Enterobacteriaceae, multidrug-resistant Pseudomonas aeruginosa, Acinetobacter baumannii, vancomycin-resistant Enterococci (VRE), and methicillin-resistant Staphylococcus aureus (MRSA). Patients must meet defined inclusion and exclusion criteria ensuring safety and appropriateness for the interventions. The FMT intervention involves administration of standardized fecal microbiota preparations in capsule form or via colonoscopy on specified days, preceded by a 5-day course of targeted antibiotics and bowel cleansing to reduce the existing gut microbial load. The probiotic arm receives a defined multi-strain probiotic preparation twice daily for 20 days following similar bowel cleansing. The diet arm follows a scientifically formulated diet designed to promote eubiosis, delivered daily for 38 days. Study visits are conducted at screening, treatment initiation, and multiple follow-up points extending to six months post-intervention to monitor safety, efficacy, and long-term outcomes. Clinical assessments include medical history, physical examination, vital signs, and laboratory testing. Biological samples such as stool, urine, saliva, and blood are collected for microbiological and genomic analyses to evaluate colonization status and mechanisms of decolonization. Sample size calculations, based on power analyses, aim to detect a clinically significant difference in decolonization rates among the groups, with 142 patients in the FMT arm and 71 patients in each comparator arm in the intention-to-treat population, accounting for anticipated dropout and screening failure rates. This experiment is designed to provide robust data on the relative efficacy and safety of FMT, probiotic therapy, and dietary modulation in eradicating ARB colonization, potentially informing future clinical practices and public health policies to combat antibiotic resistance.

Conditions

• Drug Resistance, Bacterial
• Antimicrobial Drug Resistance

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-31
• Primary completion: 2027-02-01
• Completion: 2027-04-30
• First posted: 2025-07-31
• Last updated: 2025-09-03

Locations

1 site across 1 country: Poland