UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041843 |
|---|---|
| Receipt number | R000047766 |
| Scientific Title | A study for the effect of microorganism containing foods on incident rate of infectious diseases in selected community. A randomized, double-blind, placebo-controlled, parallel-group comparison trial. |
| Date of disclosure of the study information | 2020/09/25 |
| Last modified on | 2022/04/21 16:14:06 |
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Basic information
Public title
A study for the effect of microorganism containing foods on incident rate of infectious diseases in selected community. A randomized, double-blind, placebo-controlled, parallel-group comparison trial.
Acronym
A study for the effect of microorganism containing foods on infectious diseases
Scientific Title
A study for the effect of microorganism containing foods on incident rate of infectious diseases in selected community. A randomized, double-blind, placebo-controlled, parallel-group comparison trial.
Scientific Title:Acronym
A study for the effect of microorganism containing foods on infectious diseases
Region
| Asia(except Japan) |
Condition
Condition
None(Healthy school children)
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of microorganism containing foods on incident rate of infectious diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The school absent rate of participants due to infectious diseases
Key secondary outcomes
1. General wellbeing of participants evaluated by questionnaires.
2. Z-score as nutritional status of participants
3. Severity of infectious disease like illness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily one bottle of study product including microorganism (beverage 280ml) is administered to participant for consecutive 8 weeks.
Interventions/Control_2
Daily one bottle of placebo (without microorganism, 280ml) is administered to participant for consecutive 8 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
| 6 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Provide signed and dated informed consent form after confirming the willingness of participants (guardians)
2. Willingness to comply with all study procedures for the period of the study (both participants and guardians)
3. Aged 6 to 9 years old (elementary school grades 1 to 3 equivalent)
4. Residing in selected community with Vietnam citizen (both participants and guardians)
5. No underlying chronic sickness of respiratory disease and/or gastrointestinal disease at enrollment (participants)
Key exclusion criteria
1. Unable to provide signed and dated informed consent form (guardians)
2. Unable to comply with all the study procedures (participants and guardians)
3. Allergic to milk (participants)
4. Regularly using steroid drugs (participants)
5. Person who has serious respiratory and/or gastrointestinal disease (participants)
6. Additionally, other persons whom the principal investigators deem inappropriate as participants for the study
7. Person who are currently participating in other clinical trials (participants) and who are planning to participate in other clinical trials during the trial period (participants)
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Mai |
| Middle name | Tuyet |
| Last name | Truong |
Organization
National Institute of Nutrition
Division name
National Institute of Nutrition
Zip code
-
Address
48B Tang Bat Ho, Hanoi, Vietnam
TEL
+84-24-3971-3137
truongmai1976@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Watanabe |
Organization
Kirin Holdings Co., Ltd.
Division name
Research & Development Strategy Department
Zip code
1640001
Address
10-2, Nakano 4-Chome, Tokyo, 164-0001, Japan
TEL
03-6837-7035
Homepage URL
Yuta_Watanabe@kirin.co.jp
Sponsor or person
Institute
National Institute of Nutrition
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Committee of National Institute of Nutrition, Ministry of Health, Vietnam
Address
48B Tang Bat Ho, Hanoi, Vietnam
Tel
+84 24 3971 3137
truongtuyetmai@dinhduong.org.vn
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
Ninh Binh province commune health center
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/14/3/552/htm
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/14/3/552/htm
Number of participants that the trial has enrolled
1109
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
| 2020 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 18 | Day |
Last modified on
| 2022 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047766
