UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011906 |
|---|---|
| Receipt number | R000013088 |
| Scientific Title | Probiotics Intervention for Childhood Obesity and Metabolic Syndrome |
| Date of disclosure of the study information | 2013/09/30 |
| Last modified on | 2013/10/05 09:27:31 |
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Basic information
Public title
Probiotics Intervention for Childhood Obesity and Metabolic Syndrome
Acronym
PrebioChiMeS
Scientific Title
Probiotics Intervention for Childhood Obesity and Metabolic Syndrome
Scientific Title:Acronym
PrebioChiMeS
Region
| Japan |
Condition
Condition
Obese Children
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To Assess the effectiveness of probiotics on treatment of childhood obesity and metabolic syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent over weight, BMI Z-Score
Waist circumference, Waist-to-Height ratio
Key secondary outcomes
Serum lipids, Indices of glucose metabolism
Adipo-cytokine
Indices of subclinical atherosclerosis
Base
Study type
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Probiotics (Lactobachillus casei shirota 10^9/g)
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Simple obese children
Key exclusion criteria
symptomatic obesity
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamashiro Yuichirou |
Organization
Juntendo University postgraduate course
Division name
Department of probiotics research
Zip code
Address
2-1-1, Honngou, Bunnkyou-ku
TEL
03-3813-3111
yamasiro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hara Mitsuhiko |
Organization
Tokyo Metropolitan Hiroo General Hospital
Division name
Department of pediatrics
Zip code
Address
2-34-11, Ebisu, Shibuya-ku
TEL
03-3444-1181
Homepage URL
hara@hiroo-hospital.metro.tokyo.jp
Sponsor or person
Institute
Juntendo University postgraduate course, Department of probiotics research
Institute
Department
Personal name
Funding Source
Organization
Juntendo University postgraduate course, Department of probiotics research
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京都立広尾病院小児科
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | 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
| 2013 | Year | 09 | Month | 30 | Day |
Last modified on
| 2013 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013088
