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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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10 February 2020 |
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Main ID: |
ChiCTR2000029648 |
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Date of registration:
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2020-02-09 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The dynamic alteration of gut microenvironment of moderate to severe UC patient under glucocorticoid induction of remission: an observational study
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Scientific title:
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The dynamic alteration of gut microenvironment of moderate to severe UC patient under glucocorticoid induction of remission: an observational study |
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Date of first enrolment:
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2019-11-26 |
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Target sample size:
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GC treatment:120;Health Control:30; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=49125 |
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Study type:
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Observational study |
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Study design:
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Cohort study
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Jingnan Li
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Address:
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1 Shuai-Fu-Yuan, Dongcheng District, Beijing, China
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Telephone:
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+86 10 69154804 |
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Email:
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lijn2008@163.com |
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Affiliation:
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Peking Union Medical College Hospital |
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Name:
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Pengguang Yan
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Address:
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1 Shuai-Fu-Yuan, Dongcheng District, Beijing, China
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Telephone:
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+86 10 69154804 |
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Email:
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pumcjnl@126.com |
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Affiliation:
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Peking Union Medical College Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: Aged 18-65 years, meet the diagnosis criteria of moderate to severe UC according to IBD consensus 2018
Exclusion criteria: 1. History of probiotics or antibiotics administration within last four weeks;
2. Complicated with Tumors, severe infectious diseases, and abnormal of renal or liver function;
3. Can not afford endoscopy;
4. Can not understand this clinical research.
Age minimum:
18
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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GC treatment:1mg/kg prednison or other GC with same dose;Health Control:NO intervention;
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Primary Outcome(s)
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Fecal microbiota 16S rRNA;Fecal microbiota metagenomics;
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Secondary Outcome(s)
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Fecal bile acid metabolites;Mucosal RNAseq;serological tests;
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Source(s) of Monetary Support
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CAMS Innovation Fund for Medical Sciences (No. 2016-12M-3- 001).
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Ethics review
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Status: Approved
Approval date: 26/11/2019
Contact:
chaohui Zhu
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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