UMIN-CTR Clinical Trial

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
Email	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
Email	Yuta_Watanabe@kirin.co.jp

Sponsor
Institute	National Institute of Nutrition
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047766