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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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18 April 2017 |
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Main ID: |
ChiCTR-IPR-17010306 |
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Date of registration:
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2017-01-01 |
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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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Effects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitis
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Scientific title:
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Effects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitis |
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Date of first enrolment:
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2017-02-01 |
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Target sample size:
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Group A:30; Group B:30;Group C:30;Normal control group:30; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=16696 |
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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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Post-market
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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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Wu Yanfang
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Address:
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1 North Tongdao Street, Hohhot, Inner Mongolia Autonomous Region, China
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Telephone:
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+86 13474833985 |
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Email:
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1318549484@qq.com |
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Affiliation:
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Inner Mongolia Medical University Graduate School |
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Name:
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Chen Ping
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Address:
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1 North Tongdao Street, Hohhot, Inner Mongolia Autonomous Region, China
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Telephone:
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+86 13848170137 |
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Email:
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nmgcp@sina.com |
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Affiliation:
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Affiliated Hospital of Inner Mongolia Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Meet the standard of diagnosis of UC patients with 2012 Chinese Medical Association digestive disease credits for inflammatory bowel disease treatment group developed "China's diagnosis and treatment of inflammatory bowel disease consensus opinion";
2. All patients with UC were staged and graded according to the "modified Mayo scoring system for assessing the activity of ulcerative colitis." Patients with mild to moderate UC were selected;
3. Informed consent was obtained from all participants in the study.
Exclusion criteria: (1) Age <18 years;
(2) The past 4 weeks using microbial agents, antibiotics, glucocorticoids, immunosuppressive agents;
(3) A history of abdominal surgery;
(4) Cardiovascular, respiratory, kidney, blood, endocrine and other serious diseases of the system;
(5) Severe UC patients and can not rule out the possibility of cancer;
(6) There are serious complications or coexistence of other causes of intestinal diseases are clear;
(7) Pregnant women and lactating women;
(8) If the specimen is contaminated, or if there is insufficient specimen retention.
Age minimum:
18
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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Group A:Mesalazine combined with placebo; Group B:Methalazine combined with probiotics;Group C:Probiotics combined with placebo;Normal control group:Blank control;
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Primary Outcome(s)
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Microbial door, genus, species relative content;
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Source(s) of Monetary Support
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Inner Mongolia Natural Science Foundation
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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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