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Evaluation of the Lipid-Lowering Efficacy and Safety of Akkermansia muciniphila PROBIO in Patients with Hypertriglyceridemic Acute Pancreatitis During Recovery: A Randomized, Placebo-Controlled Clinical Trial

Evaluation of the Lipid-Lowering Efficacy and Safety of Akkermansia muciniphila PROBIO in Patients with Hypertriglyceridemic Acute Pancreatitis During Recovery: A Randomized, Placebo-Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112068
Enrollment
Unknown
Registered
2025-11-10
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemic Acute Pancreatitis (HLAP) is a special subtype of acute pancreatitis caused by significantly elevated levels of triglycerides (TG) in the blood. Patients often present with primary or secondary hypertriglyceridemia, with TG levels commonly exceeding 1000 mg/dL (approximately 11.3 mmol/L). The clinical symptoms are similar to other types of acute pancreatitis and include persistent a

Interventions

Experimental group 1:Fenofibrate + Akkermansia muciniphila PROBIO live bacteria
control group:Fenofibrate + placebo
Experimental group 2:Fenofibrate + Akkermansia muciniphila PROBIO postbiotic

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18–65 years, regardless of sex. 2.Body Mass Index (BMI) >= 24.0 kg/m^2; 3.Diagnosed with hyperlipidemic acute pancreatitis, defined as: Meeting diagnostic criteria for acute pancreatitis; Serum triglyceride level >= 11.3 mmol/L; Other causes of acute pancreatitis excluded. 4.Currently in the recovery phase of pancreatitis (symptom relief, controlled inflammation, recovery of organ function, and improvement on imaging). 5.Fasting triglycerides > 5.65 mmol/L at enrollment; 6.Signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Known allergy to probiotic products; 2.Combined uncontrolled infection or severe organ failure; 3.History of antibiotic, probiotic, or immunosuppressant use within the past 2 weeks; 4.History of intestinal surgery, inflammatory bowel disease, or other conditions affecting gut microbiota; 5.Pregnant or breastfeeding women;

Design outcomes

Primary

MeasureTime frame
Triglyceride Compliance Rate;

Secondary

MeasureTime frame
Changes in gut microbiota composition;Triglyceride Compliance Rate;adverse event rate;BMI change rate;Recurrence rate of pancreatitis;

Countries

China

Contacts

Public ContactHu Yi

The first affiliated hostipal of nanchang university

360041934@qq.com+86 180 7914 0226

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026