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

NCT ID: NCT06230432

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-21

Study Completion Date

2026-12-09

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Pancreatitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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healthy control

No interventions assigned to this group

mild acute pancreatitis

No interventions assigned to this group

moderately severe acute pancreatitis

No interventions assigned to this group

severe acute pancreatitis

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role lead

Responsible Party

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Lingyu Luo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

Countries

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China

Central Contacts

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Yin Zhu, phD

Role: CONTACT

+8613970841464

Other Identifiers

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FAH of NCU gastroenterology

Identifier Type: -

Identifier Source: org_study_id

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