UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000033435