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Not Yet Recruiting NCT05722678

Study and Analysis of Acute Pancreatitis Complicated With COVID-19

Conditions: Acute Pancreatitis, 2019 Novel Coronavirus Infection

Sex: All
Healthy volunteers: 1
Enrollment: 30
Sponsor: Yuansong Sun

Summary

The goal of this observational study was to explore the complex relationship between changes in the intestinal microbiome and serum metabolites in patients with novel coronavirus infection and acute pancreatitis. The main questions it aims to answer are:Question 1: The changes of intestinal microbiota and serum metabolites in patients with novel coronavirus infection and acute pancreatitis.Question 2: The relationship between the changes in the intestinal microbiome and serum metabolites.Participants will be recruited according to certain criteria. The investigators plan to recruit 4 groups of 30 volunteers, 120 volunteers in total. It is divided into (a) AP patients without COVID-19 (normal group) (b) AP patients with COVID-19 (treatment group) (c) patients with COVID-19 infection (control group) (d) normal healthy people. The basic information of subjects, including age, sex, address, and enrollment time, was collected after enrollment. After completing the relevant preparations, start the experiment. First of all, the sample collection and detection. Blood samples were taken from 2-3ml of blood (biochemical tube) after admission or in the morning of the next day, centrifuged at 3000 rpm for 3 minutes, and stored at -80℃ within 1 hour after taking the serum; Fecal samples are stool samples retained after admission and before antibiotic use. Fecal samples need to be stored at -20℃ within one hour after collection and transferred to -80℃within 24 hours. After the retention of samples, the retained stool samples shall be tested for bacterial flora, and the blood samples shall be tested for serum metabolomics. After the test, the investigators will use the statistical software SPSS 22.0 for statistical analysis. At the same time, in order to determine the correlation between intestinal flora and clinical parameters, the investigators will use Permutation analysis of variance (PERMANOVA) to process the data.

Eligibility Criteria

Inclusion Criteria:voluntary enrollment and consent to retain biological samples for research, and signing the informed consent form;In recent 2 days, it was confirmed that COVID-19 with acute pancreatitis, and the diagnosis was clear. Among them, the diagnostic standard of acute pancreatitis is the International Consensus on Acute Pancreatitis, revised in Atlanta in 2012;Subjects did not receive treatment before enrollmentExclusion Criteria:have received treatment before hospitalization;The patient has a malignant tumor, infectious disease or allergic disease;Combined with immune diseases or other acute and chronic inflammatory diseases;The patient was diagnosed with intestinal dysfunction recently;The patient has communication or cognitive impairment

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05722678). StuddyBuddy aggregates publicly available trial information.