UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006958 |
|---|---|
| Receipt number | R000008198 |
| Scientific Title | Beneficial effects of Probiotics for obesity in children |
| Date of disclosure of the study information | 2011/12/27 |
| Last modified on | 2020/10/23 13:46:53 |
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Basic information
Public title
Beneficial effects of Probiotics for obesity in children
Acronym
Probiotics and obese children
Scientific Title
Beneficial effects of Probiotics for obesity in children
Scientific Title:Acronym
Probiotics and obese children
Region
| Japan |
Condition
Condition
obese children
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate beneficial effects on obesity in children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Impronement of obesity
Key secondary outcomes
Normalization of the intestinal microbiota, if abnormal
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Oral supplementation (probiotics)
Interventions/Control_2
Dietary intervention
Interventions/Control_3
Exercise
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
| 3 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Obesity criteria in children
Key exclusion criteria
Chronic diseases
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Yamashiro |
Organization
Juntendo University Graduate School of Medicine
Division name
Probiotics Research Laboratory
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5689-0082
yamasiro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Yamashiro |
Organization
Juntendo University Graduate School of Medicine
Division name
Probiotics Research Laboratory
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5689-0082
Homepage URL
yamasiro@juntendo.ac.jp
Sponsor or person
Institute
Probiotics Research Laboratory, Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Probiotics Research Laboratory,Juntendo University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
chiken@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
順天堂医院（東京都）、順天堂静岡病院（静岡）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
68
Results
In obesity children weight reduction resulted in obesity
Results date posted
| 2020 | Year | 10 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 08 | Month | 01 | Day |
Baseline Characteristics
In obesity children, average age 10.8 yrs
Participant flow
All participants finished the study
Adverse events
None
Outcome measures
body weight, intestinal microbiota, fecal short-chain fatty acids
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 27 | Day |
Last modified on
| 2020 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008198
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
