Condition: Hypertriglyceridemic Acute Pancreatitis · Acute Pancreatitis, Hypertriglyceridemia-induced · Hyperlipidemia · Sponsor: Jianyin Zhou
Background: Hypertriglyceridemia-associated acute pancreatitis (HTG-AP) has become the second most common cause of acute pancreatitis in China, accounting for up to 42.4% of cases, with high recurrence rates and substantial disease burden. Disease severity and recurrence risk are potentially linked to triglyceride (TG) levels. Current lipid-lowering strategies have limitations in efficacy, onset speed, or safety. Increasing evidence suggests that gut microbiota dysbiosis and impaired intestinal barrier function contribute to lipid metabolism regulation and systemic inflammation in HTG-AP patients. Probiotic supplementation may offer a novel therapeutic approach by modulating gut microbiota, improving lipid metabolism, and alleviating inflammation. Objective: To evaluate whether adjunctive treatment with Bacillus subtilis and Enterococcus faecium enteric-coated capsules (LCBE) reduces serum TG and inflammatory markers and improves clinical outcomes in mild to moderate HTG-AP patients. Methods: This is a prospective, randomized, open-label, blinded endpoint (PROBE design), single-center, parallel-group clinical trial. A total of 180 eligible participants will be randomized 1:1 to the intervention group (standard therapy plus oral LCBE 500 mg three times daily for 28 days) or control group (standard therapy alone). The primary endpoints are serum TG, C-reactive protein (CRP), and interleukin-6 (IL-6) levels on day 5 post-intervention. Secondary endpoints include TG normalizati…
This description comes directly from the study's public registry record.
Xu Hongzhi PhD · 86-0592-2292232 · xuhongzhi@xmu.edu.cn
Liu Yunpeng PhD · 86-0592-2292232 · liuyunpeng-84@163.com
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| Department of Gastroenterology, Zhongshan Hospital, Xiamen University | Xiamen, Fujian, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07720232