UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029685 |
|---|---|
| Receipt number | 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 10:43:01 |
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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
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
nmotoki@shinshu-u.ac.jp
Sponsor or person
Institute
Department of preventive medicine and public health, Shinshu university school pf medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033923
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
