UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000006958
Receipt No. 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 (Ver. 6)

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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
Email 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
Email yamasiro@juntendo.ac.jp

Sponsor
Institute Probiotics Research Laboratory, Juntendo University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008198