UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis.
Title of the study (Brief title)	Research on the Efficacy of FMT to the Children with UC
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the efficacy and proper protocol of FMT in Japanese children with UC
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of patients who improved PUCAI more than 15 and/or acheived remission (PUCAI <10) at week 5.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	2 years-old <=
Age-upper limit	18 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with ulcerative colitis diagnosed by ESPGHAN revised Porto Criteria
Key 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.
Target sample size	12

Research contact person
Name of lead principal investigator	Hirotaka Shimizu
Organization	National Center for Child Health and Development
Division name	Division of Gastroenterology
Address	Okura 2-10-1, Setagaya-ku, Tokyo, Japan
TEL	03-3416-0181
Email	shimizu-h@ncchd.go.jp

Public contact
Name of contact person	Hirotaka Shimizu
Organization	National Center for Child Health and Development
Division name	Division of Gastroenterology
Address	Okura 2-10-1, Setagaya-ku, Tokyo, Japan
TEL	03-3416-0181
Homepage URL
Email	shimizu-h@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	10Probiotics Research Laboratory, Juntendo University Graduate School of Medicine, Tokyo, Japan. Yakult Central Institute, Tokyo, Japan
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立成育医療研究センター（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 07 Month 28 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 09 Day
Last modified on	2017 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030424