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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029289
Receipt No. R000033435
Scientific Title Evaluation of effects of formulas containing oligosaccharides on the fecal microflora of young children
Date of disclosure of the study information 2017/10/02
Last modified on 2019/04/05

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Basic information
Public title Evaluation of effects of formulas containing oligosaccharides on the fecal microflora of young children
Acronym Evaluation of effects of formulas containing oligosaccharides on the fecal microflora of young children
Scientific Title Evaluation of effects of formulas containing oligosaccharides on the fecal microflora of young children
Scientific Title:Acronym Evaluation of effects of formulas containing oligosaccharides on the fecal microflora of young children
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effects of formulas containing oligosaccharides on the fecal microflora.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fecal microflora analysis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of the formula containing oligosaccharide (500mg oligosaccharide/100g of milk powder, 56g of milk powder/day, 4 weeks)
Interventions/Control_2 Intake of the formula containing oligosaccharide (1000mg oligosaccharide/100g of milk powder, 56g of milk powder/day, 4 weeks)
Interventions/Control_3 Intake of the placebo formula (0mg oligosaccharide/100g of milk powder, 56g of milk powder/day, 4 weeks)
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
12 months-old <=
Age-upper limit
34 months-old >=
Gender Male and Female
Key inclusion criteria 1) Children aged 12-34 months
2) Obtained written informed consent from the parents
3) Subjects who are judged appropriate for the study by the investigator
Key exclusion criteria 1) Subjects with food allergy
2) Breast-fed children at study entry
3) Diagnosed as having liver, renal, cardiovascular, lung, GI, blood or metabolic disease
4) Subjects who participate another study
5) Subjects who are judged inappropriate for the study by the investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Koikeda
Organization Shiba Palace Clinic
Division name Hospital director
Zip code 105-0013
Address 6F Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL 03-5408-1599
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name Miwa
Middle name
Last name Kaneko
Organization SOUKEN Co., Ltd.
Division name Secretariat
Zip code 105-0013
Address 3F Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL 03-5408-1555
Homepage URL
Email m_kaneko@mail.souken-r.com

Sponsor
Institute SOUKEN Co., Ltd.
Institute
Department

Funding Source
Organization Morinaga Milk Industry Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shiba Palace Clinic Research Ethics Committee
Address 3F Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel 03-5408-1599
Email jimukyoku@mail.souken-r.com

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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 02 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 Completed
Date of protocol fixation
2017 Year 09 Month 20 Day
Date of IRB
2017 Year 09 Month 14 Day
Anticipated trial start date
2017 Year 10 Month 24 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 06 Month 21 Day
Date trial data considered complete
2018 Year 06 Month 22 Day
Date analysis concluded
2018 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 26 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033435

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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