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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06230432
• Other study ID #: FAH of NCU gastroenterology
• Status: Not yet recruiting
• Start date: January 21, 2024
• Est. completion date: December 9, 2026

Study information

• Verified date: January 2024
• Source: The First Affiliated Hospital of Nanchang University
• Contact: Yin Zhu, phD
• Phone: +8613970841464
• Email: zhuyin27[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: December 9, 2026
• Est. primary completion date: March 9, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Patients group:

? Age between 18 and 75 years old;

? Within 72 hours of AP onset;

? AP patients who meet the 2012 Atlanta AP Classification and Diagnostic Criteria.

Healthy control group:

• Age between 18 and 75 years old; ? No history of acute pancreatitis; ? 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; ? 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; ? Unsigned informed consent form.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composition of gut microbiota	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.	through study completion, an average of 1 year
Primary	Composition of gut metabolites	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.	through study completion, an average of 1 year
Primary	Composition of metabolites in plasma	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.	through study completion, an average of 1 year
Primary	composition of proteins in plasma	Proteins are an important material foundation for life activities and the main executors of life processes such as cell proliferation, differentiation, aging, and death.	through study completion, an average of 1 year