Exploring the Mechanism of Severe Acute Pancreatitis Based on Metagenomics, Metabolomics and Prot… (NCT06230432) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Exploring the Mechanism of Severe Acute Pancreatitis Based on Metagenomics, Metabolomics and Proteomics
China176 participantsStarted 2024-01-21
Plain-language summary
The goal of this observational study is to learn about the biomarkers and mechanisms of severe acute pancreatitis in 30 healthy controls, 30 patients of mild acute pancreatitis, 30 patients of moderately severe acute pancreatitis, and 86 patients of severe acute pancreatitis. The main question it aims to answer are: • The relationship between changes in gut microbiota and clinical prognosis (plasma inflammatory cytokines, incidence and duration of infection in various parts, mortality rate), and the screening and validation of biomarkers that can be used for early prediction of disease severity. • Analyze the relationship between changes in blood composition and clinical prognosis (plasma inflammatory cytokines, incidence and duration of infection in various parts, mortality rate), screen and verify biomarkers that can be used for early prediction of disease severity. Blood and fecal samples from the healthy control group and diagnosed patients will be collected.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients group:
① Age between 18 and 75 years old;
② Within 72 hours of AP onset;
③ AP patients who meet the 2012 Atlanta AP Classification and Diagnostic Criteria.
Healthy control group:
* Age between 18 and 75 years old; ② No history of acute pancreatitis; ③ Routine laboratory tests such as blood routine and fecal routine are normal.
Exclusion Criteria:
* Used antibiotics, probiotics, and acid suppressants 4 weeks before enrollment;
* Pregnant and lactating women;
* Hypothyroidism, nephrotic syndrome, Cushing's syndrome, AIDS;
* Chronic pancreatitis, pancreatic cancer; ⑤ Severe history of cardiovascular and cerebrovascular diseases and organ dysfunction, such as malignant tumors, heart failure, coronary heart disease, chronic obstructive pulmonary disease, liver and kidney failure; ⑥ Unsigned informed consent form.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composition of gut microbiota
Timeframe: through study completion, an average of 1 year
2
Composition of gut metabolites
Timeframe: through study completion, an average of 1 year
3
Composition of metabolites in plasma
Timeframe: through study completion, an average of 1 year
4
composition of proteins in plasma
Timeframe: through study completion, an average of 1 year
Trial details
NCT IDNCT06230432
SponsorThe First Affiliated Hospital of Nanchang University