Acute PancreatitisNCT06230432
Exploring the Mechanism of Severe Acute Pancreatitis Based on Metagenomics, Metabolomics and Proteomics
An observational study of Acute Pancreatitis, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pancreatitis
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2024to 9 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
About this study
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
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy control | Not described | |
| mild acute pancreatitis | Not described | |
| moderately severe acute pancreatitis | Not described | |
| severe acute pancreatitis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start21 Jan 2024 (estimated)
- Primary completion9 Mar 2025 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingyu Luo, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230432
- Sponsor's protocol ID
- FAH of NCU gastroenterology
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Mechanism of Severe Acute Pancreatitis Based on Metagenomics, Metabolomics and Proteomics
- ClinicalTrials.gov ID
- NCT06230432
- Acronym / sponsor ID
- FAH of NCU gastroenterology
- Conditions
- Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 21 Jan 2024 (estimated)
- Primary completion
- 9 Mar 2025 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy control | – | – |
| mild acute pancreatitis | – | – |
| moderately severe acute pancreatitis | – | – |
| severe acute pancreatitis | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (4 listed)
- Used antibiotics, probiotics, and acid suppressants 4 weeks before enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yin Zhu, phD (+8613970841464, zhuyin27@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of gut microbiota (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.