UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory Research for the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis.
Acronym	FMT to the Children with UC
Scientific Title	Exploratory Research for the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis.
Scientific Title:Acronym	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	Efficacy of FMT in Japanese children with UC measured by PUCAI at 0, 1, 3, and 6 months.
Key secondary outcomes	Endoscopic score (Mayo score) Composition of microbiota in stool Fecal calprotectin Serum cytokines / chemokines

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	Maneuver
Interventions/Control_1	Fecal Microbiota Transplantation (for 6 months)
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	6 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 Patients suffering from pouchitis after the total colectomy for the ulcerative colitis
Key exclusion criteria	Patients who may require surgery for massive bleeding, toxic megacolon, or other condition. Patients with infectious colitis
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Hirotaka Middle name Last name Shimizu
Organization	National Center for Child Health and Development
Division name	Division of Gastroenterology
Zip code	157-8535
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	1st name Hirotaka Middle name Last name Shimizu
Organization	National Center for Child Health and Development
Division name	Division of Gastroenterology
Zip code	157-8535
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	MEXT(Japan)
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)

IRB Contact (For public release)
Organization	National Center for Child Health and Development
Address	Okura 2-10-1, Setagaya-ku, Tokyo, Japan
Tel	03-3416-0181
Email	hagino-k@ncchd.go.jp

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	2015 Year 10 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 01 Day
Date of IRB	2015 Year 06 Month 03 Day
Anticipated trial start date	2015 Year 10 Month 28 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2020 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 10 Month 28 Day
Last modified on	2020 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022583