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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011906
Receipt No. 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

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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
Email 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
Email hara@hiroo-hospital.metro.tokyo.jp

Sponsor
Institute Juntendo University postgraduate course, Department of probiotics research
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013088

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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