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

NCT06230432 | Not Yet Recruiting

• 1 other identifier: FAH of NCU gastroenterology
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (4)

healthy control

mild acute pancreatitis

moderately severe acute pancreatitis

severe acute pancreatitis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 healthy controls, 30 patients of mild acute pancreatitis, 30 patients of moderately severe acute pancreatitis and 86 patients of severe acute pancreatitis, a total of 176 cases were included.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Yin Zhu, phD

CONTACT

+8613970841464; zhuyin27@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 30, 2024
• Study Start: January 21, 2024
• Primary Completion: March 9, 2025
• Study Completion (Estimated): December 9, 2026
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CN (1)