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.
Not Applicable
- Conditions
- one(Healthy school children)
- Registration Number
- JPRN-UMIN000041843
- Lead Sponsor
- ational Institute of Nutrition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1109
Inclusion Criteria
Not provided
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The school absent rate of participants due to infectious diseases
- Secondary Outcome Measures
Name Time Method 1. General wellbeing of participants evaluated by questionnaires. 2. Z-score as nutritional status of participants 3. Severity of infectious disease like illness