UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019526 |
|---|---|
| Receipt number | R000022583 |
| Scientific Title | Exploratory Research for the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis. |
| Date of disclosure of the study information | 2015/10/28 |
| Last modified on | 2020/07/17 11:12:29 |
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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
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
shimizu-h@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022583
