UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000023885
Receipt No. R000027512
Scientific Title Randomized controlled trial of the influence on mucosal regulatory T cells and fecal butyric acid by administration of Clostridium butyricum and resistant starch for pediatric ulcerative colitis
Date of disclosure of the study information 2016/09/01
Last modified on 2020/09/04 (Ver. 7)

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Basic information
Public title Randomized controlled trial of the influence on mucosal regulatory T cells and fecal butyric acid by administration of Clostridium butyricum and resistant starch for pediatric ulcerative colitis
Acronym Randomized controlled trial of the influence on mucosal regulatory T cells and fecal butyric acid by administration of Clostridium butyricum and resistant starch for pediatric ulcerative colitis
Scientific Title Randomized controlled trial of the influence on mucosal regulatory T cells and fecal butyric acid by administration of Clostridium butyricum and resistant starch for pediatric ulcerative colitis
Scientific Title:Acronym Randomized controlled trial of the influence on mucosal regulatory T cells and fecal butyric acid by administration of Clostridium butyricum and resistant starch for pediatric ulcerative colitis
Region
Japan

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

Objectives
Narrative objectives1 To examine the frequency of relapse in pediatric ulcerative colitis patients, mucosal regulatry T cells and fecal butyric acid by the administration of Clostridium butyricum and resistant starch compared with conventional treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the frequency of relapse in pediatric ulcerative colitis patients by the administration for 12 months.
Key secondary outcomes mucosal regulatory T cells and fecal butyric acid by the administration for more than 1 month

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 Clostridium butyricum 3g of once, 3 times a day and resistant starch 10g of once, 2 times a day for 52 weeks.
Interventions/Control_2 Controls.
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
8 years-old <=
Age-upper limit
19 years-old >
Gender Male and Female
Key inclusion criteria Pediatric ulcerative colitis patients aged from 8 year old to less than 19 year old with the agreement.
Key exclusion criteria Patients with refusal for informed consent, and judged inappropriate.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Kudo
Organization juntendo University Hospital
Division name Department of Pediatrics and Adolescent Medicine
Zip code 113-8431
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 0338133111
Email t-kudo@juntendo.ac.jp

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Kudo
Organization juntendo University Hospital
Division name Department of Pediatrics and Adolescent Medicine
Zip code 113-8431
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 0338133111
Homepage URL
Email t-kudo@juntendo.ac.jp

Sponsor
Institute juntendo University
Institute
Department

Funding Source
Organization juntendo University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization juntendo University Hospital
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
Tel 0338133111
Email t-kudo@juntendo.ac.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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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 0
Results 
The study was terminated because it did not lead to case enrollment and the study period ended.
Results date posted
2020 Year 09 Month 04 Day
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
2016 Year 08 Month 25 Day
Date of IRB
2016 Year 07 Month 29 Day
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 01 Day
Last modified on
2020 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027512