Clinical trial for Hypertriglyceridemic Acute Pancreatitis
Official title Bacillus Subtilis and Enterococcus Faecium Probiotic Plus Lipid-Lowering Therapy for Hypertriglyceridemic Acute Pancreatitis: A Prospective RCT
ClinicalTrials.gov ID: NCT07720232
What this study is testing
What is Live Combined Bacillus subtilis and Enterococcus faecium Enteric-coated Capsules (LCBE)?
An investigational oral probiotic being studied for hypertriglyceridemic acute pancreatitis.
Also referred to as Meichangan.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if adding probiotic capsules to usual treatment can lower blood triglycerides and inflammation, and improve recovery in patients with pancreatitis caused by high triglycerides.
- Who it's for
- Adults with mild or moderate pancreatitis caused by high triglyceride levels.
- What's involved
- Participants will take probiotic capsules (500 mg, three times a day) for 28 days while receiving standard care, and will have blood tests and other measurements taken during the study.
- Time commitment
- The study lasts about a month; participants will have regular hospital visits and blood tests, especially around day 5 and at the end of the 28‑day period.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Meet the diagnostic criteria for hypertriglyceridemia-associated acute pancreatitis (HTG-AP): fulfill the AP diagnostic criteria and concurrent...
- 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...
- Age between 18 and 65 years.
You likely can't join if
- 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...
- 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;
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Xiamen, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Xiamen, Fujian, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.