NCT06156956

Fecal Microbiota Transplantation (FMT) to Decolonize Antibiotic - Resistant Bacteria (ARB) - New Protocol

Fecal Microbiota Transplantation to Eradicate Antibiotic-resistance Bacteria From the Gastrointestinal Tract of Patients at High Risk of Infection and/or to Cut Off the Spread of Bacteria With Dangerous Mechanisms of Antibiotic Resistance

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Human Biome Institute S.A. · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

The aim of the study is to assess the safety and efficacy of new protocol fecal microbiota transplantation (FMT) in the eradication of antibiotic resistant bacteria, including those featuring of resistance to new generation antibiotics. This study should answer the following research questions: 1. Will new treatment protocol and fully anaerobic FMT be effective in decolonization of ARB? 2. Will FMT improve the prognosis and quality of life in patients at high risk of ARB infection?

Detailed description

Fecal microbiota transplantation (FMT) was shown to be very efficient in treatment of relapsed and refractory Clostridium difficile infection and became a standard treatment. The investigators company produces and uses FMT not only in case of Clostridioides difficile colitis, but also in case of gut colonization with antibiotic-resistant bacteria and other indications as a clinical studies under Bioethical Committee approval. Company's flagship program to decolonize ARB is based on assumption that physiological gut flora may outcompete the pathogenic bacteria similarly as in case of Clostridium difficile and lead to loss of colonization. Patients colonized with ARB are characterized by poor diversity of gut microbiome (dysbiosis), which makes them vulnerable to further infections. In case of gut mucosa injury and severe immune suppression, these colonizing bacteria may cause severe systemic infections. During this interventional prospective, single arm, observational study, the investigators collect the information about the safety and effectiveness of FMT in gut decolonization with antibiotic-resistance bacteria (ARB) using their new treatment protocol and own full-spectrum, full-richness, full-viability anaerobic FMT. The project protocol is based on the intervention (fecal microbiota transplantation; FMT) in capsules (or colonoscopy if per os route is not possible) applied twice - on day 7th after procedure initiation and between day 9-14 within extended period, low dose (1/6th every day) application. All patient are premedicated with non-absorbable antibiotics on days 1-5 and a bowel cleansing on day 6 from the screening. After the end of the eradication procedure, the patient proceeds to the follow-up assessment stage and is observed up to 360 days with longitudinal samples collection.

Conditions

• Drug Resistance, Bacterial
• Antimicrobial Drug Resistance

Interventions

Type	Name	Description
PROCEDURE	Fecal Microbiota Transplantation	Fecal Microbiota Transplantation in capsules or suspension obtained from healthy unrelated donor introduced two times per treatment: for capsules - FMT administration: day 7 (full dose) and days from 9 to 14 (prolonged intake regimen) for suspension - FMT administration: day 7 and day 14

Timeline

• Start date: 2023-10-27
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-12-05
• Last updated: 2023-12-05

Locations

5 sites across 1 country: Poland