Impact of intestinal dysbiosis on clinical course in severe acute pancreatitis: a multicenter prospective observational study

BackgroundDysbiosis, an imbalance of the intestinal microbiota in critically ill patients, reportedly contributes to poor outcomes. Controlling the disruption of intestinal homeostasis could be promising tactics for infectious complications in acute pancreatitis. To improve the mortality rate of severe acute pancreatitis with high frequency of infectious complications, it is warranted to elucidate the pathophysiology for development of new treatment strategies. We hypothesized that patients with severe acute pancreatitis would demonstrate gut dysbiosis, leading to an onset of infectious complications and poor outcomes. MethodsWe will conduct a prospective study to compare the sequential changes in intestinal microbiota using 16s RNA metagenomics and metabolomics between patients with severe acute pancreatitis and mild acute pancreatitis. We will enroll adult patients (18 years of age or older) diagnosed with acute pancreatitis and newly admitted to the hospitals for 48 hours or longer. We will exclude patients with inflammatory bowel disease, patients with diarrhea prior to admission, patients who have received antimicrobial agents for more than 1 week in the 2 months prior to admission. We will collect stool and blood samples on day 1 and 6. The primary outcome is changes in various parameters of the intestinal microbiota, protein concentration in stool, and metabolite concentration. The secondary outcomes include relationship between each parameter and short- and long-term prognosis, correlation of each parameter with treatment details and clinical course during ICU stay, and associations among the amount of diarrhea and alpha-diversity parameters, protein concentration in each stool, and metabolite concentration.