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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029685
Receipt No. R000033923
Scientific Title Effect of ingestion of test food on infection in infants: double-blind randomized placebo-controlled trial.
Date of disclosure of the study information 2017/12/11
Last modified on 2020/04/27

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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/ctr_e/ctr_view.cgi?recptno=R000033923

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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