UMIN-CTR Clinical Trial

Basic information
Public title	Effect of ingestion of test food on infection in infants: double-blind randomized placebo-controlled trial.
Acronym	Effect of ingestion of test food on infection in infants: double-blind randomized placebo-controlled trial.
Scientific Title	Effect of ingestion of test food on infection in infants: double-blind randomized placebo-controlled trial.
Scientific Title:Acronym	Effect of ingestion of test food on infection in infants: double-blind randomized placebo-controlled trial.
Region	Japan

Condition
Condition	Infectious disease
Classification by specialty	Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aim to evaluate the effect and safety of ingestion of test food or placebo on prevention of infectious disease in infants of nursery school.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Symptom incidence of respiratory infection and intestinal infection
Key secondary outcomes	Symptom severity of respiratory infection and intestinal infection

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test food (low food) for 13 weeks.
Interventions/Control_2	Ingestion of placebo for 13 weeks.
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	12 months-old <=
Age-upper limit	32 months-old >=
Gender	Male and Female
Key inclusion criteria	1) Persons whose age is 12 months or more and 32 months or less at the start of intakeperiod. 2) Persons who gained written consent based on his / her guardian's free will after having received sufficient explanation for participation in this study.
Key exclusion criteria	1) Persons who have allergy to milk, soybeans. 2) Persons who are taking breast milk. 3) Those who regularly consume food containing milk containing an active ingredient and who can not stop taking intake during the study period. 4) Persons who have serious diseases in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine metabolic system, or those who have serious medical history of these. 5) In addition, peasons whose research managers judged inappropriate as subjects.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Tetsuo Middle name Last name Nomiyama
Organization	Shinshu university school of medicine
Division name	Department of preventive medicine and public health
Zip code	390-8621
Address	Asahi 3-1-1, Matsumoto, Nagano, Japan
TEL	0263-37-2622
Email	nomiyama@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Noriko Middle name Last name Motoki
Organization	Shinshu university school of medicine
Division name	Department of preventive medicine and public health
Zip code	390-8621
Address	Asahi 3-1-1, Matsumoto, Nagano, Japan
TEL	0263-37-2622
Homepage URL
Email	nmotoki@shinshu-u.ac.jp

Sponsor
Institute	Department of preventive medicine and public health, Shinshu university school pf medicine
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	the Ethics Review Committee of Shinshu University School of Medicine
Address	Asahi 3-1-1, Matsumoto, Nagano, Japan
Tel	0263-37-2572
Email	mdrinri@shinshu-u.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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 11 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 10 Month 17 Day
Date of IRB	2017 Year 10 Month 17 Day
Anticipated trial start date	2017 Year 11 Month 08 Day
Last follow-up date	2018 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 24 Day
Last modified on	2020 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033923