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Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 65

Bacillus subtilis and Enterococcus faecium Probiotic Plus Lipid-Lowering Therapy for HTG-AP

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

Run by Zhongshan Hospital Xiamen University · NCT07720232 · Data updated 2026-11-12

This trial tests whether adding a probiotic capsule to standard lipid-lowering therapy helps people with mild HTG-AP see lower triglycerides and better recovery.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment180 (estimated)
SponsorZhongshan Hospital Xiamen University
Academic / other
Locations1 site (Xiamen, Fujian)
StatusRecruiting
StartedJanuary 18, 2026
Main results expectedJanuary 18, 2028
Study endsFebruary 18, 2029
Registry record updatedJuly 22, 2026
Trial IDNCT07720232 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18-65 with mild HTG-AP diagnosed within 72 hours of onset and no major organ dysfunction or conflicting conditions.

Probably not a fit

Patients with severe pancreatitis, other etiologies of pancreatitis, or recent antibiotic/probiotic use may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, phase 4 trial evaluates the effect of live combined Bacillus subtilis and Enterococcus faecium enteric-coated capsules (LCBE) in addition to standard care for adults with mild hypertriglyceridemia-associated acute pancreatitis. Participants receive LCBE alongside routine treatments such as fenofibrate, fluids, and pain management, with outcomes including triglyceride levels and inflammatory markers. The study aims to determine if LCBE can improve lipid metabolism, reduce inflammation, and improve clinical outcomes compared with standard care alone. Enrollment targets adults 18-65 diagnosed within 72 hours of symptom onset, with strict exclusions to ensure participant safety and disease specificity. The trial is conducted at Zhongshan Hospital, Xiamen University, under a lead sponsor with no listed collaborators.

Why it matters

Potential benefit: If successful, patients could experience faster TG reduction and improved recovery in HTG-AP when LCBE is added to standard therapy.

How similar studies have gone: Previous work suggests probiotics can modulate gut microbiota and inflammation, but robust RCT evidence in HTG-AP is limited and this trial addresses that gap.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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.
2. 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.
3. Admission within 72 hours of symptom onset.
4. 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.
5. Age between 18 and 65 years.
6. No history of allergy to microbiological agents.
7. Signed informed consent obtained.

Exclusion Criteria:

1. Concurrent biliary, alcoholic, or other etiologies of acute pancreatitis;
2. Acute exacerbation of chronic pancreatitis or pancreatic tumor;
3. 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;
4. Severe hepatic or renal dysfunction (serum creatinine \>177 μmol/L or ALT \>150 U/L);
5. Active infection, malignancy, immunodeficiency, or requiring long-term use of immunosuppressants;
6. Diagnosed diabetes mellitus;
7. Pregnancy or breastfeeding;
8. History of lactose intolerance;
9. 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.

Where it's running

  • Department of Gastroenterology, Zhongshan Hospital, Xiamen University
    Xiamen, Fujian, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.