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Hypertriglyceridemic Acute PancreatitisPhase 4NCT07720232

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

A Phase 4 study testing Live Combined Bacillus subtilis and Enterococcus faecium Enteric-coated Capsules (LCBE) in people with Hypertriglyceridemic Acute Pancreatitis and Acute Pancreatitis, Hypertriglyceridemia-induced, run by Jianyin Zhou at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Live Combined Bacillus subtilis and Enterococcus faecium Enteric-coated Capsules (LCBE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
18 Jan 2026to 18 Feb 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xu Hongzhi PhD contact

86-0592-2292232

xuhongzhi@xmu.edu.cn

Liu Yunpeng PhD contact

86-0592-2292232

liuyunpeng-84@163.com

China1 site, 1 recruiting

  • Department of Gastroenterology, Zhongshan Hospital, Xiamen University

    Xiamen, Fujian, 361004

    Xu hongzhi PhD, 86-0592-2292232, xuhongzhi@xmu.edu.cn

    Liu Yunpeng PhD, 86-0592-2292232, liuyunpeng-84@163.com

    Recruiting

Other trials in China

About this study

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

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.

Read more

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.

Read the detailed description

Rationale:

Timely reduction of serum TG is critical for improving prognosis in HTG-AP. However, conventional therapies-including fibrates, insulin, heparin, and blood purification-have limitations related to onset speed, invasiveness, cost, and adverse effects. Preclinical and clinical studies suggest that Bacillus subtilisand Enterococcus faecium(LCBE) can improve lipid metabolism, restore gut microbial balance, enhance intestinal barrier function, and reduce systemic inflammation. Nevertheless, robust prospective RCT evidence focusing on TG dynamics in HTG-AP remains lacking.

Study Population and Setting:

Adult patients (18-65 years) diagnosed with mild HTG-AP (serum TG ≥11.3 mmol/L or 5.65-11.3 mmol/L with lactescent serum) within 72 hours of symptom onset will be enrolled from the Department of Gastroenterology, Zhongshan Hospital, Xiamen University. Patients with severe or moderately severe AP, other etiologies of AP, significant organ dysfunction, pregnancy, immunosuppression, diabetes mellitus, lactose intolerance, or recent use of antibiotics/probiotics will be excluded.

Intervention and Follow-up:

Participants will receive standard care according to the 2021 Chinese Expert Consensus on Emergency Management of HTG-AP, including fenofibrate, low-molecular-weight heparin, fluid resuscitation, somatostatin, ulinastatin, proton-pump inhibitors, nutritional support, and pain management. In addition, the intervention group will receive LCBE 500 mg (2 capsules) orally three times daily for 28 days. Follow-up visits are scheduled at baseline, day 5, day 14, and day 28, with serial assessments of TG, lipid profile, inflammatory cytokines, glucose metabolism, gut microbiota (16S rRNA sequencing), intestinal barrier biomarkers (D-lactate, endotoxin, DAO, zonulin), clinical symptoms, severity scores, and quality of life (EQ-5D-5L).

Statistical Analysis:

Analyses will follow the intention-to-treat principle, with per-protocol analysis as sensitivity analysis. Continuous variables will be compared using t-tests or Mann-Whitney U tests; categorical variables will be analyzed using chi-square or Fisher's exact tests. Microbiome diversity will be assessed using Shannon index, PERMANOVA, and LEfSe analysis. An independent Data Safety Monitoring Board will conduct one interim analysis when 50% enrollment is reached.

Ethical Considerations:

The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Written informed consent will be obtained from all participants. The trial is approved by the Institutional Review Board of Zhongshan Hospital, Xiamen University

Being tested
Live Combined Bacillus subtilis and Enterococcus faecium Enteric-coated Capsules (LCBE), Standard Care (in control arm)
Keywords
Hypertriglyceridemic Acute Pancreatitis, Probiotics, Bacillus subtilisand Enterococcus faecium, LCBE
Medical subject headings
Pancreatitis, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Meichangan

    LCBE 500 mg (2 capsules) orally three times daily for 28 ± 2 days, initiated within 24 hours after confirmation of eligibility.

  • Standard Care (in control arm)Drug

    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.

Study groups in NCT07720232
Study groupRoleWhat they receive
Standard Care combined LCBEExperimentalLCBE 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.
Receives: Drug: Live Combined Bacillus subtilis and Enterococcus faecium Enteric-coated Capsules (LCBE); Drug: Standard Care (in control arm)
Standard Care OnlyActive comparatorPatients 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.
Receives: Drug: Standard Care (in control arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Concentration of Serum Triglycerides (TG) in mmol/L at 5 ± 2 days.

    Blood samples will be collected after a minimum 8-hour fast. Serum triglycerides (TG) will be measured quantitatively using an enzymatic colorimetric assay on an automated clinical chemistry analyzer in the central laboratory of Xiamen University Zhongshan Hospital. The primary endpoint is the mean concentration of serum TG (in mmol/L) at the intervention visit occurring 5 ± 2 days after randomization. Values are presented as the mean (standard deviation, SD).

    Measured: Baseline through Day 5 (±2 days)

  2. Serum Concentration of C-Reactive Protein (CRP) at Day 5 (±2 days)

    Fasting venous blood samples will be collected at the Day 5 (±2 days) visit. Serum CRP will be quantified using a high-sensitivity immunoturbidimetric assay, and will be presented as Mean (Standard Deviation) in mg/L.

    Measured: Baseline through Day 5 (±2 days)

  3. Serum Concentration of Interleukin-6 (IL-6) at Day 5 (±2 days)

    Fasting venous blood samples will be collected at the Day 5 (±2 days) visit. Serum IL-6 will be measured via chemiluminescence immunoassay. Data will be presented as Mean (Standard Deviation) in pg/mL.

    Measured: Baseline through Day 5 (±2 days)

Secondary outcomes (16)

  1. Mean Concentration of Serum Triglycerides (TG) in mmol/L at 14 ± 2 days

    Blood samples will be collected after a minimum 8-hour fast. Serum triglycerides (TG) will be measured quantitatively using an enzymatic colorimetric assay on an automated clinical chemistry analyzer in the central laboratory of Xiamen University Zhongshan Hospital. The primary endpoint is the mean concentration of serum TG (in mmol/L) at the intervention visit occurring 14 ± 2 days after randomization. Values are presented as the mean (standard deviation, SD).

    Measured: Baseline through Day 14 (±2 days)

  2. Mean Concentration of Serum Triglycerides (TG) in mmol/L at 28 ± 2 days

    Blood samples will be collected after a minimum 8-hour fast. Serum triglycerides (TG) will be measured quantitatively using an enzymatic colorimetric assay on an automated clinical chemistry analyzer in the central laboratory of Xiamen University Zhongshan Hospital. The primary endpoint is the mean concentration of serum TG (in mmol/L) at the intervention visit occurring 28 ± 2 days after randomization. Values are presented as the mean (standard deviation, SD).

    Measured: Baseline through Day 28 (±2 days)

  3. Serum Concentration of C-Reactive Protein (CRP) at Day 14 (±2 days)

    Fasting venous blood samples will be collected at the Day 14 (±2 days) visit. Serum CRP will be quantified using a high-sensitivity immunoturbidimetric assay, and will be presented as Mean (Standard Deviation) in mg/L.

    Measured: Baseline through Day 14 (±2 days)

  4. Serum Concentration of C-Reactive Protein (CRP) at Day 28 (±2 days)

    Fasting venous blood samples will be collected at the Day 28 (±2 days) visit. Serum CRP will be quantified using a high-sensitivity immunoturbidimetric assay, and will be presented as Mean (Standard Deviation) in mg/L.

    Measured: Baseline through Day 28 (±2 days)

  5. Percentage of Participants Achieving Serum Triglyceride (TG) Normalization (<1.7 mmol/L) at Day 5 (±2 days)

    Serum TG levels will be measured from fasting blood samples collected at the Day 5 (±2 days) visit. Normalization is defined as a TG level <1.7 mmol/L. The outcome is the percentage of participants meeting this criterion at this specific timepoint.

    Measured: Baseline through Day 5 (±2 days)

  6. Percentage of Participants Achieving Serum Triglyceride (TG) Normalization (<1.7 mmol/L) at Day 14 (±2 days)

    Serum TG levels will be measured from fasting blood samples collected at the Day 14 (±2 days) visit. Normalization is defined as a TG level <1.7 mmol/L. The outcome is the percentage of participants meeting this criterion at this specific timepoint.

    Measured: Baseline through Day 14 (±2 days)

  7. Percentage of Participants Achieving Serum Triglyceride (TG) Normalization (<1.7 mmol/L) at Day 28 (±2 days)

    Serum TG levels will be measured from fasting blood samples collected at the Day 28 (±2 days) visit. Normalization is defined as a TG level <1.7 mmol/L. The outcome is the percentage of participants meeting this criterion at this specific timepoint.

    Measured: Baseline through Day 28 (±2 days)

  8. Percentage Change from Baseline in Serum Triglyceride (TG) Concentration at Day 5 (±2 days)

    The percentage change will be calculated using the formula: [(TG at Day 5) - (TG at Baseline)] / (TG at Baseline) × 100%. Fasting blood samples will be collected at both timepoints. A negative value indicates a reduction in TG levels. Data will be presented as Mean (Standard Deviation, SD).

    Measured: Baseline through Day 5 (±2 days)

  9. Percentage Change from Baseline in Serum Triglyceride (TG) Concentration at Day 14 (±2 days)

    The percentage change will be calculated using the formula: [(TG at Day 14) - (TG at Baseline)] / (TG at Baseline) × 100%. A negative value indicates a reduction in TG levels. Data will be presented as Mean (SD).

    Measured: Baseline through Day 14 (±2 days)

  10. Percentage Change from Baseline in Serum Triglyceride (TG) Concentration at Day 28 (±2 days)

    The percentage change will be calculated using the formula: [(TG at Day 28) - (TG at Baseline)] / (TG at Baseline) × 100%. A negative value indicates a reduction in TG levels. Data will be presented as Mean (SD).

    Measured: Baseline through Day 28 (±2 days)

  11. Percentage Change from Baseline in Serum C-Reactive Protein (CRP) at Day 5 (±2 days)

    The percentage change will be calculated as: [(CRP at Day 5) - (CRP at Baseline)] / (CRP at Baseline) × 100%. Serum CRP will be measured using a high-sensitivity immunoturbidimetric assay. A negative value indicates a reduction in systemic inflammation. Data will be presented as Median (Interquartile Range, IQR).

    Measured: Baseline through Day 5 (±2 days)

  12. Percentage Change from Baseline in Serum C-Reactive Protein (CRP) at Day 14 (±2 days)

    The percentage change will be calculated as: [(CRP at Day 14) - (CRP at Baseline)] / (CRP at Baseline) × 100%. A negative value indicates a reduction in systemic inflammation. Data will be presented as Median (IQR).

    Measured: Baseline through Day 14 (±2 days)

  13. Percentage Change from Baseline in Serum C-Reactive Protein (CRP) at Day 28 (±2 days)

    The percentage change will be calculated as: [(CRP at Day 28) - (CRP at Baseline)] / (CRP at Baseline) × 100%. A negative value indicates a reduction in systemic inflammation. Data will be presented as Median (IQR).

    Measured: Baseline through Day 28 (±2 days)

  14. Percentage Change from Baseline in Serum Interleukin-6 (IL-6) at Day 5 (±2 days)

    The percentage change will be calculated as: [(IL-6 at Day 5) - (IL-6 at Baseline)] / (IL-6 at Baseline) × 100%. Serum IL-6 will be measured using a chemiluminescence immunoassay or ELISA. Data will be presented as Median (Interquartile Range, IQR).

    Measured: Baseline through Day 5 (±2 days)

  15. Change from Baseline in Gut Microbiota Alpha and Beta Diversity Indices Assessed by 16S rRNA Sequencing

    Fecal samples will be collected at Baseline, Day 5, Day 14, and Day 28. Gut microbiota composition will be profiled using 16S rRNA gene sequencing (V3-V4 regions). Alpha diversity (including Shannon, Simpson, Chao1, and Observed OTUs indices) and beta diversity (using Bray-Curtis dissimilarity and Weighted UniFrac distances) will be calculated via the QIIME2 pipeline. Changes from baseline at each timepoint will be evaluated. LEfSe analysis will identify differentially abundant taxa (LDA score >2.0, P<0.05).

    Measured: Baseline through Day 28 (±2 days)

  16. Change from Baseline in Serum Intestinal Barrier Biomarkers (D-lactate, Endotoxin, DAO, Zonulin)

    Fasting venous blood samples will be collected at Baseline, Day 5 (±2 days), Day 14 (±2 days), and Day 28 (±2 days). Serum will be separated and stored at -80°C until batch analysis. Biomarker concentrations will be measured using commercially available ELISA kits: D-lactate by enzymatic spectrophotometry, endotoxin by the chromogenic limulus amebocyte lysate (LAL) assay, diamine oxidase (DAO) by ELISA, and zonulin by ELISA. Changes from baseline at each timepoint will be calculated. Data will be presented as Mean (Standard Deviation, SD) or Median (Interquartile Range, IQR) as appropriate. These biomarkers will be correlated with gut microbiota profiles and clinical outcomes.

    Measured: Baseline through Day 28 (±2 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2026
  2. Study start18 Jan 2026
  3. Primary completion18 Jan 2028 (estimated)
  4. Study completion18 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07720232
Sponsor's protocol ID
XUZH20260005
Status last verified
Jul 2026
First submitted
3 Jul 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) underlying the primary and secondary outcomes will be shared. This includes de-identified baseline characteristics, clinical measurements (e.g., serum triglyceride levels, lipid profiles, CRP, IL-6, HOMA-IR, TyG), intestinal barrier biomarkers, 16S rRNA gene sequencing data (processed OTU/ASV tables), and safety data (adverse events). The study protocol and statistical analysis plan will also be available. Data will be accessible beginning 12 months after publication and ending 36 months after publication. Researchers with scientifically valid proposals approved by an independent review committee will be granted access upon signing a data sharing agreement.

Publications

  • Ranson JH, Rifkind KM, Roses DF, Fink SD, Eng K, Spencer FC. Prognostic signs and the role of operative management in acute pancreatitis. Surg Gynecol Obstet. 1974 Jul;139(1):69-81. No abstract available.

    PubMed 4834279

  • Wu BU, Johannes RS, Sun X, Tabak Y, Conwell DL, Banks PA. The early prediction of mortality in acute pancreatitis: a large population-based study. Gut. 2008 Dec;57(12):1698-703. doi: 10.1136/gut.2008.152702. Epub 2008 Jun 2.

    PubMed 18519429

  • Knaus WA, Zimmerman JE, Wagner DP, Draper EA, Lawrence DE. APACHE-acute physiology and chronic health evaluation: a physiologically based classification system. Crit Care Med. 1981 Aug;9(8):591-7. doi: 10.1097/00003246-198108000-00008.

    PubMed 7261642

  • Mortele KJ, Wiesner W, Intriere L, Shankar S, Zou KH, Kalantari BN, Perez A, vanSonnenberg E, Ros PR, Banks PA, Silverman SG. A modified CT severity index for evaluating acute pancreatitis: improved correlation with patient outcome. AJR Am J Roentgenol. 2004 Nov;183(5):1261-5. doi: 10.2214/ajr.183.5.1831261.

    PubMed 15505289

  • Kee Jang D, Kyu Lee J, Yung Jung C, Ho Kim K, Ra Kang H, Sun Lee Y, Hwa Yoon J, Ro Joo K, Kyu Chae M, Hyeon Baek Y, Seo BK, Hyub Lee S, Lim C. Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: A three-arm randomized controlled trial. J Integr Med. 2023 Nov;21(6):537-542. doi: 10.1016/j.joim.2023.10.004. Epub 2023 Nov 2.

    PubMed 37973472

  • Tenner S, Vege SS, Sheth SG, Sauer B, Yang A, Conwell DL, Yadlapati RH, Gardner TB. American College of Gastroenterology Guidelines: Management of Acute Pancreatitis. Am J Gastroenterol. 2024 Mar 1;119(3):419-437. doi: 10.14309/ajg.0000000000002645. Epub 2023 Nov 7.

    PubMed 38857482

  • Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

    PubMed 23100216

  • Pi X, Teng W, Fei D, Zhao G, Liu W. Effects of Live Combined Bacillus subtilis and Enterococcus faecium on Gut Microbiota Composition in C57BL/6 Mice and in Humans. Front Cell Infect Microbiol. 2022 Feb 10;12:821662. doi: 10.3389/fcimb.2022.821662. eCollection 2022.

    PubMed 35223547

  • Elshaghabee FMF, Rokana N, Gulhane RD, Sharma C, Panwar H. Bacillus As Potential Probiotics: Status, Concerns, and Future Perspectives. Front Microbiol. 2017 Aug 10;8:1490. doi: 10.3389/fmicb.2017.01490. eCollection 2017.

    PubMed 28848511

  • Wan YD, Zhu RX, Bian ZZ, Sun TW. Effect of probiotics on length of hospitalization in mild acute pancreatitis: A randomized, double-blind, placebo-controlled trial. World J Gastroenterol. 2021 Jan 14;27(2):224-232. doi: 10.3748/wjg.v27.i2.224.

    PubMed 33510561

  • Guo L, Meng M, Wei Y, Lin F, Jiang Y, Cui X, Wang G, Wang C, Guo X. Protective Effects of Live Combined B. subtilis and E. faecium in Polymicrobial Sepsis Through Modulating Activation and Transformation of Macrophages and Mast Cells. Front Pharmacol. 2019 Jan 21;9:1506. doi: 10.3389/fphar.2018.01506. eCollection 2018.

    PubMed 30719003

  • Wu Y, Wu H, Yi H. Efficacy of interventions with live combined Bacillus subtilis and Enterococcus faecium enteric-coated capsules in metabolic associated fatty liver disease patients: a meta-analysis of randomized controlled trials. Front Pharmacol. 2025 May 27;16:1610426. doi: 10.3389/fphar.2025.1610426. eCollection 2025.

    PubMed 40495889

  • Jiang J, Xiong J, Ni J, Chen C, Wang K. Live Combined B. subtilis and E. faecium Alleviate Liver Inflammation, Improve Intestinal Barrier Function, and Modulate Gut Microbiota in Mice with Non-Alcoholic Fatty Liver Disease. Med Sci Monit. 2021 Sep 5;27:e931143. doi: 10.12659/MSM.931143.

    PubMed 34482357

  • Huang J, Huang J, Yin T, Lv H, Zhang P, Li H. Enterococcus faecium R0026 Combined with Bacillus subtilis R0179 Prevent Obesity-Associated Hyperlipidemia and Modulate Gut Microbiota in C57BL/6 Mice. J Microbiol Biotechnol. 2021 Feb 28;31(2):181-188. doi: 10.4014/jmb.2009.09005.

    PubMed 33144552

  • Mo SJ, Lee K, Hong HJ, Hong DK, Jung SH, Park SD, Shim JJ, Lee JL. Effects of Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on Overweight and the Gut Microbiota in Humans: Randomized, Double-Blinded, Placebo-Controlled Clinical Trial. Nutrients. 2022 Jun 15;14(12):2484. doi: 10.3390/nu14122484.

    PubMed 35745214

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Live Combined Bacillus subtilis and Enterococcus faecium Enteric-coated Capsules (LCBE) in people with Hypertriglyceridemic Acute Pancreatitis and Acute Pancreatitis, Hypertriglyceridemia-induced, run by Jianyin Zhou at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xu Hongzhi PhD (86-0592-2292232, xuhongzhi@xmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Concentration of Serum Triglycerides (TG) in mmol/L at 5 ± 2 days. (time frame: Baseline through Day 5 (±2 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07720232, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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