Microbiota Transplantation Among Patients Receiving Long-Term Care: The Sentinel REACT Nonrandomized Clinical Trial

Area of Science:

• Infectious Diseases
• Gastroenterology
• Microbiology

Background:

• Intestinal multidrug-resistant organism (MDRO) colonization is common in long-term acute care hospital (LTACH) patients, increasing infection and transmission risks.
• Current FDA-approved therapies to reduce intestinal MDRO colonization are lacking.

Purpose of the Study:

• To assess the safety and acceptability of fecal microbiota transplantation (FMT) in LTACH patients colonized with MDROs.

Main Methods:

• A single-center, open-label, nonrandomized clinical trial involving 42 LTACH patients (10 FMT recipients, 32 controls).
• FMT was administered via gastrostomy tube or enema without antibiotic or bowel preparation.
• Safety was assessed via adverse events for up to 6 months; MDRO colonization was monitored via perirectal cultures.

Main Results:

• FMT was safe and well-tolerated, with no serious adverse events attributed to the procedure; mild solicited adverse events were reported.
• While all FMT recipients still had MDROs at the final visit, post hoc analyses suggested potential numerical reductions in bacteremia, intestinal pathogen dominance, and antibiotic use compared to controls.
• These observed differences did not reach statistical significance, likely due to the study's limited sample size.

Conclusions:

• Fecal microbiota transplantation (FMT) is a safe and acceptable intervention for LTACH patients with MDRO colonization.
• Preliminary findings suggest potential benefits of FMT in reducing bacteremia, pathogen dominance, and antibiotic usage.
• Larger, randomized controlled trials are warranted to definitively evaluate the efficacy of FMT in this patient population.