Bacillus Subtilis and Enterococcus Faecium Probiotic Plus Lipid-Lowering Therapy for Hypertriglyceridemic Acute Pancreatitis: A Prospective RCT
18 de julho de 2026 atualizado por: Jianyin Zhou
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.
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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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
Tipo de estudo
Intervencional
Inscrição (Estimado)
180
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Xu hongzhi PhD
- Número de telefone: 86-0592-2292232
- E-mail: xuhongzhi@xmu.edu.cn
Estude backup de contato
- Nome: Liu Yunpeng PhD
- Número de telefone: 86-0592-2292232
- E-mail: liuyunpeng-84@163.com
Locais de estudo
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Fujian
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Xiamen, Fujian, China, 361004
- Recrutamento
- Department of Gastroenterology, Zhongshan Hospital, Xiamen University
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Contato:
- Xu hongzhi PhD
- Número de telefone: 86-0592-2292232
- E-mail: xuhongzhi@xmu.edu.cn
-
Contato:
- Liu Yunpeng PhD
- Número de telefone: 86-0592-2292232
- E-mail: liuyunpeng-84@163.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Standard Care combined LCBE
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.
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Medicamento: Live Combined Bacillus subtilis and Enterococcus faecium Enteric-coated Capsules (LCBE)
LCBE 500 mg (2 capsules) orally three times daily for 28 ± 2 days, initiated within 24 hours after confirmation of eligibility.
Outros nomes:
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.
|
|
Comparador Ativo: Standard Care Only
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.
|
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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Concentration of Serum Triglycerides (TG) in mmol/L at 5 ± 2 days.
Prazo: Baseline through Day 5 (±2 days)
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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).
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Baseline through Day 5 (±2 days)
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Serum Concentration of C-Reactive Protein (CRP) at Day 5 (±2 days)
Prazo: Baseline through Day 5 (±2 days)
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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.
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Baseline through Day 5 (±2 days)
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Serum Concentration of Interleukin-6 (IL-6) at Day 5 (±2 days)
Prazo: Baseline through Day 5 (±2 days)
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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.
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Baseline through Day 5 (±2 days)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean Concentration of Serum Triglycerides (TG) in mmol/L at 14 ± 2 days
Prazo: Baseline through Day 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).
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Baseline through Day 14 (±2 days)
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Mean Concentration of Serum Triglycerides (TG) in mmol/L at 28 ± 2 days
Prazo: Baseline through Day 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).
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Baseline through Day 28 (±2 days)
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Serum Concentration of C-Reactive Protein (CRP) at Day 14 (±2 days)
Prazo: Baseline through 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.
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Baseline through Day 14 (±2 days)
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Serum Concentration of C-Reactive Protein (CRP) at Day 28 (±2 days)
Prazo: Baseline through 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.
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Baseline through Day 28 (±2 days)
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Percentage of Participants Achieving Serum Triglyceride (TG) Normalization (<1.7 mmol/L) at Day 5 (±2 days)
Prazo: Baseline through Day 5 (±2 days)
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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.
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Baseline through Day 5 (±2 days)
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Percentage of Participants Achieving Serum Triglyceride (TG) Normalization (<1.7 mmol/L) at Day 14 (±2 days)
Prazo: Baseline through Day 14 (±2 days)
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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.
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Baseline through Day 14 (±2 days)
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Percentage of Participants Achieving Serum Triglyceride (TG) Normalization (<1.7 mmol/L) at Day 28 (±2 days)
Prazo: Baseline through 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.
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Baseline through Day 28 (±2 days)
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Percentage Change from Baseline in Serum Triglyceride (TG) Concentration at Day 5 (±2 days)
Prazo: Baseline through Day 5 (±2 days)
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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).
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Baseline through Day 5 (±2 days)
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Percentage Change from Baseline in Serum Triglyceride (TG) Concentration at Day 14 (±2 days)
Prazo: Baseline through Day 14 (±2 days)
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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).
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Baseline through Day 14 (±2 days)
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Percentage Change from Baseline in Serum Triglyceride (TG) Concentration at Day 28 (±2 days)
Prazo: Baseline through Day 28 (±2 days)
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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).
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Baseline through Day 28 (±2 days)
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Percentage Change from Baseline in Serum C-Reactive Protein (CRP) at Day 5 (±2 days)
Prazo: Baseline through 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).
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Baseline through Day 5 (±2 days)
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Percentage Change from Baseline in Serum C-Reactive Protein (CRP) at Day 14 (±2 days)
Prazo: Baseline through 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).
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Baseline through Day 14 (±2 days)
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Percentage Change from Baseline in Serum C-Reactive Protein (CRP) at Day 28 (±2 days)
Prazo: Baseline through 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).
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Baseline through Day 28 (±2 days)
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Percentage Change from Baseline in Serum Interleukin-6 (IL-6) at Day 5 (±2 days)
Prazo: Baseline through 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).
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Baseline through Day 5 (±2 days)
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Change from Baseline in Gut Microbiota Alpha and Beta Diversity Indices Assessed by 16S rRNA Sequencing
Prazo: Baseline through Day 28 (±2 days)
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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).
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Baseline through Day 28 (±2 days)
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Change from Baseline in Serum Intestinal Barrier Biomarkers (D-lactate, Endotoxin, DAO, Zonulin)
Prazo: Baseline through Day 28 (±2 days)
|
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.
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Baseline through Day 28 (±2 days)
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time to Abdominal Pain Relief
Prazo: From randomization up to Day 28 (±2 days)
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Abdominal pain intensity will be assessed every 2 hours by nursing staff using a Visual Analogue Scale (VAS; 0-100 mm) blinded to group allocation.
Abdominal pain relief is defined as the time from randomization to the first instance when the VAS score decreases to ≤30 (mild pain or less) and remains at or below this level for at least 12 consecutive hours without rescue analgesia.
Patients requiring surgical intervention, discharged, or experiencing a serious adverse event prior to achieving relief will be censored at the time of that event.
Data will be presented as Median Time (Interquartile Range, IQR)
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From randomization up to Day 28 (±2 days)
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Time to Successful Oral Feeding
Prazo: From randomization up to Day 28 (±2 days)
|
Defined as the time from randomization to the first instance when the participant tolerates a regular or semi-solid diet without experiencing recurrence of moderate to severe abdominal pain (Visual Analogue Scale, VAS >30) or other gastrointestinal symptoms (e.g., nausea, vomiting, abdominal distension) for at least 24 consecutive hours.
Dietary tolerance will be assessed daily by the attending physician or study nurse blinded to group allocation.
Patients requiring surgical intervention, discharged, or experiencing a serious adverse event prior to achieving successful oral feeding will be censored at the time of that event.
Data will be presented as Median Time (Interquartile Range, IQR).
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From randomization up to Day 28 (±2 days)
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Length of Hospital Stay
Prazo: From admission to discharge, up to Day 28 (±2 days)
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Defined as the number of calendar days from the date of hospital admission to the date of discharge (discharge criteria: absence of abdominal pain, tolerance of solid food, and normalization of inflammatory markers).
For participants transferred to another facility (e.g., ICU) or those who die during hospitalization, the length of stay will be censored at the date of the last known status.
Data will be presented as Median (Interquartile Range, IQR) in days.
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From admission to discharge, up to Day 28 (±2 days)
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Total Hospitalization Cost
Prazo: From admission to discharge, up to Day 28 (±2 days)
|
Total direct medical costs incurred from admission to discharge will be extracted from the hospital's electronic billing system.
Costs include expenses related to medications (including study drugs), laboratory tests, imaging examinations, bed occupancy, surgical procedures, and medical consumables.
All costs will be converted to Chinese Yuan (CNY) and adjusted for inflation if necessary.
Costs for participants transferred to other facilities (e.g., ICU) or those who die during hospitalization will be calculated up to the date of the last known status.
Data will be presented as Median (Interquartile Range, IQR) due to the typically skewed distribution of cost data.
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From admission to discharge, up to Day 28 (±2 days)
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Rate of Intensive Care Unit (ICU) Admission During Hospitalization
Prazo: From admission to discharge, up to Day 28 (±2 days)
|
Defined as the proportion of participants who require transfer to or direct admission into an intensive care unit (ICU) at any point during the index hospitalization.
This includes transfers for respiratory failure, hemodynamic instability, or organ support (e.g., mechanical ventilation, continuous renal replacement therapy).
The outcome is assessed via daily review of medical records and nursing flow sheets.
Data will be presented as a percentage with a 95% Confidence Interval (CI).
Participants who die prior to a potential ICU transfer will be counted as having met the endpoint.
|
From admission to discharge, up to Day 28 (±2 days)
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Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Prazo: From randomization to end of treatment (Day 28 ± 2 days)
|
Adverse Events (AEs) and Serious Adverse Events (SAEs) will be monitored continuously from the time of informed consent until the end of the follow-up period (Day 28).
AEs will be classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0.
The severity (Grade 1-5) and relationship to the study intervention (certain, probable/likely, possible, unlikely, unrelated) will be assessed by the investigator.
SAEs will be reported to the Institutional Review Board and the sponsor within 24 hours.
The incidence will be calculated as the number of participants experiencing at least one event divided by the total number of participants in each arm.
Data will be presented as the number of participants (n) and percentage (%) with corresponding 95% Confidence Intervals.
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From randomization to end of treatment (Day 28 ± 2 days)
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Quality of Life Assessed by EuroQol 5-Dimension 5-Level (EQ-5D-5L) Utility Score
Prazo: Baseline through Day 28 (±2 days)
|
Health-related quality of life (HRQoL) will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, a standardized generic instrument covering 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Participants will complete the questionnaire independently at Baseline, Day 5 (±2 days), Day 14 (±2 days), and Day 28 (±2 days) under the guidance of study staff blinded to group allocation.
Utility scores will be derived using the Chinese adult population preference-based scoring algorithm, with a theoretical range of -0.391 (worst possible health state, equivalent to coma/death) to 1.0 (full health).
Higher scores indicate better HRQoL; lower scores reflect greater impairment in daily functioning and well-being.
Data will be presented as Mean (Standard Deviation, SD), with sensitivity analyses using Median (Interquartile Range, IQR) if data deviate from normality.
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Baseline through Day 28 (±2 days)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
18 de janeiro de 2026
Conclusão Primária (Estimado)
18 de janeiro de 2028
Conclusão do estudo (Estimado)
18 de fevereiro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
3 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de julho de 2026
Primeira postagem (Real)
22 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Metabólicas
- Doenças do aparelho digestivo
- Doenças pancreáticas
- Dislipidemias
- Distúrbios do metabolismo lipídico
- Doenças Nutricionais e Metabólicas
- Pancreatite
- Hiperlipidemias
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Qualidade de assistência médica
- Indicadores de qualidade, assistência médica
- Padrão de atendimento
Outros números de identificação do estudo
- XUZH20260005
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
Beginning 12 months after publication, ending 36 months after publication.
Critérios de acesso de compartilhamento IPD
With whom? Researchers who provide a methodologically sound proposal, approved by an independent review committee.
How to request? Email to corresponding author; data sharing agreement required. Access criteria ? Approval by the Data Access Committee of Dept. of Gastroenterology, Zhongshan Hospital, Xiamen University.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .