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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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4 February 2019 |
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Main ID: |
ChiCTR1900021229 |
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Date of registration:
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2019-02-02 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The role of fecal calprotectin in the treatment of patients with clinically quiescent ulcerative colitis
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Scientific title:
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The role of fecal calprotectin in the treatment of patients with clinically quiescent ulcerative colitis |
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Date of first enrolment:
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2019-02-18 |
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Target sample size:
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Intervention group:74;Control group:74; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=35791 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Other
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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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Haiyun Shi
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Address:
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95 Yong'an Road, Xicheng District, Beijing, China
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Telephone:
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+86 010 63139842 |
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Email:
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shihaiyun1016@gmail.com |
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Affiliation:
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Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University |
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Name:
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Haiyun Shi
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Address:
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95 Yong'an Road, Xicheng District, Beijing, China
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Telephone:
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+86 010 63139842 |
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Email:
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shihaiyun1016@gmail.com |
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Affiliation:
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Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with confirmed diagnosis of UC will be included if all of the following criteria are met:
1) Aged at least 18 years;
2) In clinical remission (Mayo clinical subscore: stool frequency = 1 and rectal bleeding =0) for at least 1 month;
3) On oral mesalamine =2g/day for at least 1 month;
4) Written informed consent obtained.
Exclusion criteria: Patients will be excluded if:
1) Prior bowel operation (except for appendicectomy), or
2) Receive corticosteroids or immunosuppressants in the past 2 months, or
3) Allegic to mesalamine or intolerant to high dose of mesalamine, or
4) Pregnancy or lactating women.
Age minimum:
Age maximum:
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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Intervention group:Increasing the dose of mesalamine according to fecal calprotectin levels;Control group:Maintaining current dosage of mesalamine;
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Primary Outcome(s)
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Mucosal healing;
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Source(s) of Monetary Support
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Investigator initiated
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Ethics review
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Status: Approved
Approval date: 05/12/2018
Contact:
Yan Cui
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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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