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Exploring the Mechanism of Severe Acute Pancreatitis Based on Metagenomics, Metabolomics and Proteomics

Exploring the Mechanism of Severe Acute Pancreatitis Based on Metagenomics, Metabolomics and Proteomics

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06230432
Enrollment
176
Registered
2024-01-30
Start date
2024-01-21
Completion date
2026-12-09
Last updated
2024-01-30

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

Conditions

Acute Pancreatitis

Brief 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.

Interventions

None listed

Sponsors

The First Affiliated Hospital of Nanchang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Composition of gut microbiotathrough study completion, an average of 1 yearThe gut microbiota plays an important role in protecting the intestinal barrier, regulating metabolism, and participating in immune responses in the human body, and is an important component of the gut ecosystem.
Composition of gut metabolitesthrough study completion, an average of 1 yearMetabolites can reveal the intrinsic correlation between metabolic products and physiological and pathological changes in the body, thereby achieving recognition of the overall state of the body.
Composition of metabolites in plasmathrough study completion, an average of 1 yearMetabolites can reveal the intrinsic correlation between metabolic products and physiological and pathological changes in the body, thereby achieving recognition of the overall state of the body.
composition of proteins in plasmathrough study completion, an average of 1 yearProteins are an important material foundation for life activities and the main executors of life processes such as cell proliferation, differentiation, aging, and death.

Countries

China

Contacts

Primary ContactYin Zhu, phD
zhuyin27@sina.com+8613970841464

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026