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NCT07720232

Overview

NCT ID: NCT07720232
Lead Sponsor: Jianyin ZhouOTHER
Official Title: Effect of Bacillus Subtilis and Enterococcus Faecium Combination Therapy Combined With Conventional Lipid-Lowering Treatment on Triglyceride Levels in Patients With Hypertriglyceridemic Acute Pancreatitis: A Prospective Randomized Controlled Trial
Brief Summary: 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 normalization rate (<1.7 mmol/L), lipid profile, inflammatory markers, glucose metabolism parameters, gut microbiota composition, intestinal barrier integrity, symptom relief, length of hospital stay, healthcare costs, quality of life, and safety.

Expected Impact: This study aims to provide high-level evidence for probiotic adjunctive therapy in HTG-AP and to explore underlying mechanisms from the perspective of gut microbiota modulation.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Jan 18, 2026Actual
Primary Completion Date: Jan 18, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Meet at least two of the three characteristic criteria for AP:① Acute onset of persistent upper abdominal pain;② Serum amylase and/or lipase activity at least three times above the upper limit of normal;③ Imaging findings on CT, MRI, or abdominal ultrasonography.

Meet the diagnostic criteria for hypertriglyceridemia-associated acute pancreatitis (HTG-AP): fulfill the AP diagnostic criteria and concurrent hypertriglyceridemia (serum triglycerides ≥11.3 mmol/L or 5.65-11.3 mmol/L with lactescent serum), with exclusion of other common causes of AP such as cholelithiasis and alcoholism.

Admission within 72 hours of symptom onset.

Disease severity assessed as mild acute pancreatitis (MAP) within 48 hours of admission, defined by absence of organ dysfunction and absence of local or systemic complications.

Age between 18 and 65 years.

No history of allergy to microbiological agents.

Signed informed consent obtained.

Exclusion Criteria:

Concurrent biliary, alcoholic, or other etiologies of acute pancreatitis;

Acute exacerbation of chronic pancreatitis or pancreatic tumor;

Severe hypertriglyceridemia-associated acute pancreatitis, defined as: ① patients classified as moderately severe or severe AP according to the Expert Consensus on the Diagnosis and Treatment of Hypertriglyceridemic Acute Pancreatitis; ② within 48 hours, meeting any one of the following criteria: modified Marshall score ≥2, MCTSI score ≥4, APACHE II score ≥15, BISAP score ≥3, or Ranson score ≥3; patients meeting any of these criteria are excluded;

Severe hepatic or renal dysfunction (serum creatinine >177 μmol/L or ALT >150 U/L);

Active infection, malignancy, immunodeficiency, or requiring long-term use of immunosuppressants;

Diagnosed diabetes mellitus;

Pregnancy or breastfeeding;

History of lactose intolerance;

Use within 4 weeks prior to enrollment of antibiotics, probiotics, prebiotics, synbiotics, or other microbiological agents, as well as gastrointestinal motility drugs (e.g., domperidone, mosapride) or other medications that may significantly affect gut microbiota or gastrointestinal function.

Study Plan

Study Type: Interventional
Phase: Phase 4
Enrollment: 180Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: Xu Hongzhi PhDContact
xuhongzhi@xmu.edu.cn86-0592-2292232

Similar Studies

Participant Group/Arms

Standard Care combined LCBEExperimental

LCBE refers to live combined Bacillus subtilis and Enterococcus faecium enteric-coated capsules. The dosage and treatment duration are as follows: LCBE 500 mg (2 capsules) administered orally three times daily for 28 ± 2 days, initiated within 24 hours after confirmation of eligibility. Standard care was administered in accordance with the 2021 Chinese Expert Consensus on the Emergency Diagnosis and Treatment of Hypertriglyceridemic Acute Pancreatitis. This regimen encompassed fenofibrate and low-molecular-weight heparin, alongside goal-directed fluid resuscitation. Additional symptomatic and supportive therapies included somatostatin and ulinastatin administration, proton pump inhibitor therapy, nutritional support, and analgesia management.

Drug: Live Combined Bacillus subtilis and Enterococcus faecium Enteric-coated Capsules (LCBE)

Drug: Standard Care (in control arm)

Standard Care OnlyActive Comparator

Patients in the control group received standard care exclusively, in accordance with the 2021 Chinese Expert Consensus on the Emergency Diagnosis and Treatment of Hypertriglyceridemic Acute Pancreatitis. This regimen encompassed fenofibrate and low-molecular-weight heparin, alongside goal-directed fluid resuscitation. Comprehensive symptomatic and supportive therapies included somatostatin and ulinastatin infusions, proton pump inhibitor therapy, nutritional support, and analgesia management.

Drug: Standard Care (in control arm)