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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.

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. - A study for the effect of microorganism containing foods on infectious diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041843
Enrollment
1000
Registered
2020-09-25
Start date
2020-09-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None(Healthy school children)

Interventions

Daily one bottle of study product including microorganism (beverage 280ml) is administered to participant for consecutive 8 weeks. Daily one bottle of placebo (without microorganism, 280ml) is adminis

Sponsors

National Institute of Nutrition
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
The school absent rate of participants due to infectious diseases

Secondary

MeasureTime frame
1. General wellbeing of participants evaluated by questionnaires. 2. Z-score as nutritional status of participants 3. Severity of infectious disease like illness

Countries

Asia(except Japan)

Contacts

Public ContactYuta Watanabe

Kirin Holdings Co., Ltd. Research & Development Strategy Department

Yuta_Watanabe@kirin.co.jp03-6837-7035

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026