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Not yet recruitingNCT06230432Updated Jan 30, 2024

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

An observational study in Acute Pancreatitis, sponsored by The First Affiliated Hospital of Nanchang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by The First Affiliated Hospital of Nanchang University · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
176
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Acute Pancreatitis

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03

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's planned enrollment of 176 is close to the median of 180 across 277 observational studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

The First Affiliated Hospital of Nanchang University is the lead sponsor of 26 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
176 participants (estimated)
Patient registry
No

Groups and cohorts

  • healthy control
  • mild acute pancreatitis
  • moderately severe acute pancreatitis
  • severe acute pancreatitis
06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

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Study locations

1 site
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330006, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06230432
Lead sponsor
The First Affiliated Hospital of Nanchang University
Responsible party
Lingyu Luo (Professor, The First Affiliated Hospital of Nanchang University) — Principal investigator
First posted
Jan 30, 2024
Start date
Jan 21, 2024 (estimated)
Primary completion
Mar 9, 2025 (estimated)
Completion
Dec 9, 2026 (estimated)
Last update
Jan 30, 2024

Study contacts

Yin Zhu, phD
Contact
zhuyin27@sina.com
+8613970841464

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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