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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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000026485 |
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Date of registration:
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10/03/2017 |
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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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Research on the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis.
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Scientific title:
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Research on the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis. - Research on the Efficacy of FMT to the Children with UC |
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Date of first enrolment:
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2016/08/01 |
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Target sample size:
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12 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030424 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hirotaka Shimizu |
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Address:
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Okura 2-10-1, Setagaya-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3416-0181 |
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Email:
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shimizu-h@ncchd.go.jp |
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Affiliation:
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National Center for Child Health and Development Division of Gastroenterology |
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Name:
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Hirotaka Shimizu |
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Address:
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Okura 2-10-1, Setagaya-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3416-0181 |
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Email:
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shimizu-h@ncchd.go.jp |
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Affiliation:
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National Center for Child Health and Development Division of Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Patients who may require surgery for massive bleeding, toxic megacolon, or other condition. Patients with infectious colitis. Patients with HBV, HCV, or HIV. Patients who regarded as imappropriate for enrollment by physician.
Age minimum:
2years-old
Age maximum:
18years-old
Gender:
Male and Female
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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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Fecal Microbiota Transplantation(on Day1, 2 and 3, week 2, 3 and 5) after antibiotic pretreatment using amoxicillin 40mg/kg/day, fosfomycin 100mg/kg/day and metronidazole 16mg/kg/day.
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Primary Outcome(s)
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Proportion of patients who improved PUCAI more than 15 and/or acheived remission (PUCAI <10) at week 5.
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Source(s) of Monetary Support
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Ministry of Education, Culture, Sports, Science and Technology
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Ethics review
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Status: YES
Approval date:
Contact:
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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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