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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 2019/02/26

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Middle name
Last name Yuichiro Yamashiro
Organization Juntendo University Graduate School of Medicine
Division name Probiotics Research Laboratory
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5689-0082
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuichiro Yamashiro
Organization Juntendo University Graduate School of Medicine
Division name Probiotics Research Laboratory
Zip code
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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 順天堂医院(東京都)、順天堂静岡病院(静岡)、井上てるクリニック(東京都)

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
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 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
2019 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008198


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