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

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.

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Composition of gut microbiota

Time frame: through study completion, an average of 1 year

The 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 metabolites

Time frame: through study completion, an average of 1 year

Metabolites 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 plasma

Time frame: through study completion, an average of 1 year

Metabolites 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 plasma

Time frame: through study completion, an average of 1 year

Proteins are an important material foundation for life activities and the main executors of life processes such as cell proliferation, differentiation, aging, and death.

Study contacts

Contact information is provided by the study sponsor or research team.

Yin Zhu, phD

CONTACT

[email protected]

+8613970841464

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Nanchang University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Jan 30, 2024
Registry last updated: Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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