Randomized Double-Blind Study of Gut Microbiota Transplantation for Moderate to Severe Acute Pancreatitis Treatment

What this Trial Is About

Researchers are evaluating the safety and effectiveness of fecal microbiota transplantation FMT in patients with moderate to severe acute pancreatitis. This randomized, double-blind, placebo-controlled trial aims to prevent late complications of this condition by comparing FMT with a placebo treatment. The study is conducted at a single center and involves 80 patients who meet specific diagnosis and health criteria. Participants are randomly assigned to one of two groups one receives a daily injection of FMT bacterial solution through a nasojejunal nutrition tube for five days, while the other group receives a placebo injection of physiological saline via the same method and schedule. Before FMT, patients undergo intestinal preparation, and the treatment starts once intestinal function is restored and inflammatory signs improve. Use of probiotics, antibiotics, and other drugs affecting gut microbiota is restricted during the study. Throughout the trial, patients undergo thorough evaluations before, during, and after treatment, including safety and efficacy assessments. Researchers monitor pancreatic infectious complications over approximately one year, along with changes in pancreatitis severity scores, gut microbiome, gut barrier health, and inflammatory markers up to three months. The study involves careful observation to understand how FMT impacts recovery and complications in acute pancreatitis patients.

Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis