Fecal Microbiota Transplantation for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis: A Multicenter, Randomized, Double-Blind Clinical Trial

What this Trial Is About

Researchers are evaluating whether fecal microbiota transplantation (FMT) can help prevent infectious complications in patients experiencing the late phase of moderately severe or severe acute pancreatitis. This multicenter, randomized, double-blind, placebo-controlled trial aims to better understand if FMT combined with standard treatment improves outcomes compared to placebo with standard treatment. The study involves approximately 150 participants across multiple centers in China and seeks to improve patient care and quality of life by investigating infection prevention and other health aspects. Participants will be randomly assigned to receive either FMT liquid or a placebo, both administered as a 100 mL solution via a nasojejunal tube once daily for five consecutive days, alongside standard care. The FMT liquid consists of processed healthy donor fecal microbiota in sterile saline, while the placebo is sterile saline alone, designed to look identical to maintain blinding. This intervention period is followed by monitoring and evaluation to compare effects between groups. During the study, participants will undergo assessments of infection rates within 30 and 90 days, organ function, nutritional status, gastrointestinal symptoms, and gut microbiota changes at multiple time points. Researchers will also track the need for additional surgeries or treatments, mortality, antibiotic use, and overall healthcare utilization. Safety and effectiveness measures will be collected from enrollment through hospital discharge and follow-up periods up to 90 days, providing comprehensive data on the intervention's impact.

FMT for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis