Study and Analysis of Acute Pancreatitis Complicated With COVID-19

NCT05722678 | Unknown

• 1 other identifier: KY20221224
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Pancreatitis; 2019 Novel Coronavirus Infection

Keywords

Novel coronavirus infection; Acute pancreatitis; Intestinal flora; Serum metabolism

Outcome Measures

Primary Outcomes (2)

• Changes of intestinal microflora abundance in feces

  The relationship between the abundance of each common bacteria in the feces of patients in the experimental group and the change of the normal control group

  through study completion, an average of 6 months

• Changes of metabolic indexes in blood samples

  The change relationship between the common laboratory metabolic blood indicators in the blood of patients in the experimental group and the normal control group

  through study completion, an average of 6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 (control group) (d) normal healthy people.

You may qualify if:

• 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 enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuansong Sun: lead
• Anhui Medical University: collaborator
• Nanjing University: collaborator

Related Publications (13)

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  PMID: 28381378 BACKGROUND

• Schietroma M, Pessia B, Carlei F, Mariani P, Sista F, Amicucci G. Intestinal permeability and systemic endotoxemia in patients with acute pancreatitis. Ann Ital Chir. 2016;87:138-44.

  PMID: 27179282 BACKGROUND

• Gao R, Wu C, Zhu Y, Kong C, Zhu Y, Gao Y, Zhang X, Yang R, Zhong H, Xiong X, Chen C, Xu Q, Qin H. Integrated Analysis of Colorectal Cancer Reveals Cross-Cohort Gut Microbial Signatures and Associated Serum Metabolites. Gastroenterology. 2022 Oct;163(4):1024-1037.e9. doi: 10.1053/j.gastro.2022.06.069. Epub 2022 Jul 1.

  PMID: 35788345 BACKGROUND

• Li XY, He C, Zhu Y, Lu NH. Role of gut microbiota on intestinal barrier function in acute pancreatitis. World J Gastroenterol. 2020 May 14;26(18):2187-2193. doi: 10.3748/wjg.v26.i18.2187.

  PMID: 32476785 BACKGROUND

• Majumder J, Minko T. Recent Developments on Therapeutic and Diagnostic Approaches for COVID-19. AAPS J. 2021 Jan 5;23(1):14. doi: 10.1208/s12248-020-00532-2.

  PMID: 33400058 BACKGROUND

• Chilamakuri R, Agarwal S. COVID-19: Characteristics and Therapeutics. Cells. 2021 Jan 21;10(2):206. doi: 10.3390/cells10020206.

  PMID: 33494237 BACKGROUND

• Yoshikawa T, Watanabe T, Kamata K, Hara A, Minaga K, Kudo M. Intestinal Dysbiosis and Autoimmune Pancreatitis. Front Immunol. 2021 Mar 23;12:621532. doi: 10.3389/fimmu.2021.621532. eCollection 2021.

  PMID: 33833754 BACKGROUND

• Wang Z, Li F, Liu J, Luo Y, Guo H, Yang Q, Xu C, Ma S, Chen H. Intestinal Microbiota - An Unmissable Bridge to Severe Acute Pancreatitis-Associated Acute Lung Injury. Front Immunol. 2022 Jun 14;13:913178. doi: 10.3389/fimmu.2022.913178. eCollection 2022.

  PMID: 35774796 BACKGROUND

• Zhu Y, Mei Q, Fu Y, Zeng Y. Alteration of gut microbiota in acute pancreatitis and associated therapeutic strategies. Biomed Pharmacother. 2021 Sep;141:111850. doi: 10.1016/j.biopha.2021.111850. Epub 2021 Jun 30.

  PMID: 34214727 BACKGROUND

• Ye S, Si C, Deng J, Chen X, Kong L, Zhou X, Wang W. Understanding the Effects of Metabolites on the Gut Microbiome and Severe Acute Pancreatitis. Biomed Res Int. 2021 Oct 19;2021:1516855. doi: 10.1155/2021/1516855. eCollection 2021.

  PMID: 34712726 BACKGROUND

• Hasan MR, Suleiman M, Perez-Lopez A. Metabolomics in the Diagnosis and Prognosis of COVID-19. Front Genet. 2021 Jul 23;12:721556. doi: 10.3389/fgene.2021.721556. eCollection 2021.

  PMID: 34367265 BACKGROUND

• Liu R, Hong J, Xu X, Feng Q, Zhang D, Gu Y, Shi J, Zhao S, Liu W, Wang X, Xia H, Liu Z, Cui B, Liang P, Xi L, Jin J, Ying X, Wang X, Zhao X, Li W, Jia H, Lan Z, Li F, Wang R, Sun Y, Yang M, Shen Y, Jie Z, Li J, Chen X, Zhong H, Xie H, Zhang Y, Gu W, Deng X, Shen B, Xu X, Yang H, Xu G, Bi Y, Lai S, Wang J, Qi L, Madsen L, Wang J, Ning G, Kristiansen K, Wang W. Gut microbiome and serum metabolome alterations in obesity and after weight-loss intervention. Nat Med. 2017 Jul;23(7):859-868. doi: 10.1038/nm.4358. Epub 2017 Jun 19.

  PMID: 28628112 BACKGROUND

• Han M, Huang Y, Gui H, Xiao Y, He M, Liu J, Cao X, Zheng M, Lu M, Jia W, Li H, Wang X, Zhang N, Kong SA, Liu X, Wu Y, Wu F, Huang S. Dynamic changes in host immune system and gut microbiota are associated with the production of SARS-CoV-2 antibodies. Gut. 2023 Oct;72(10):1996-1999. doi: 10.1136/gutjnl-2022-327561. Epub 2022 Oct 7. No abstract available.

  PMID: 36207022 BACKGROUND

MeSH Terms

Conditions

Pancreatitis; COVID-19

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: attending doctor

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 10, 2023
• Study Start: February 15, 2023
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share