Probiotic Capsules with Bacillus subtilis and Enterococcus faecium Combined with Standard Lipid-Lowering Therapy for Adults with Mild Hypertriglyceridemic Acute Pancreatitis

What this Trial Is About

Hypertriglyceridemia-associated acute pancreatitis HTG-AP is a significant cause of acute pancreatitis in China, with high recurrence and disease burden. This study aims to evaluate whether adding probiotic treatment with Bacillus subtilis and Enterococcus faecium capsules LCBE to standard lipid-lowering therapy improves clinical outcomes, reduces serum triglycerides TG, and lowers inflammatory markers in adults with mild to moderate HTG-AP. Participants are randomized to receive either standard care alone or combined with LCBE capsules 500 mg, two capsules, orally three times daily for 28 days. Standard care includes lipid-lowering drugs such as fenofibrate and low-molecular-weight heparin, fluid resuscitation, somatostatin, ulinastatin, proton pump inhibitors, nutritional support, and pain management. Follow-up visits are scheduled at baseline, day 5, day 14, and day 28 to monitor treatment effects. During the study, participants undergo regular assessments including measurements of serum triglycerides, inflammatory markers CRP and IL-6, glucose metabolism parameters, and gut microbiota composition using 16S rRNA sequencing. Intestinal barrier health is evaluated through biomarkers like D-lactate, endotoxin, DAO, and zonulin. Clinical symptoms, severity scores, quality of life, and safety are also closely monitored throughout the 28-day treatment period.

Bacillus Subtilis and Enterococcus Faecium Probiotic Plus Lipid-Lowering Therapy for Hypertriglyceridemic Acute Pancreatitis: A Prospective RCT