UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023885 |
|---|---|
| Receipt number | 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 15:05:08 |
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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
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
t-kudo@juntendo.ac.jp
Sponsor or person
Institute
juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027512
