This is a study to evaluate the effects of a prebiotic, AHCC, a standardized extract of cultured Lentinula edodes mycelia, on immunologic markers and the incidence of respiratory tract infections in children.
Children aged 4-6 years old at the time of enrolment
Good nutritional status with weight-for-height > -2, and height-for-age z-score > -2 based on WHO growth standards
Infants in a group setting (daycare centers).
No congenital disorder
Presence of chronic illnesses or conditions (congenital disorder, genetic syndromes, congenital heart disease, chronic renal failure, cystic fibrosis, etc)
Children who have participated in another clinical intervention study within the past 30 days.
Children who are likely to be transferred to another facility that is not part of the study before completing the follow-up period
Parallel
a prebiotic, that us a standardized extract of cultured Lentinula edodes mycelia
Dietary supplementSubjects will be administered dextrin including AHCC.
Placebo (dextrin)
Dietary supplementSubjects will be administered dextrin alone (placebo)
Incidence of Respiratory Tract Infection
the number incidence of infections, specifically respiratory tract infection, by looking at the number of febrile days (\>37.5 ◦C) during the test period.
additional immunological effects
immunomodulatory effects of AHCC, we will be checking serum IFN-γ as a biomarker of immunity at baseline and 3 months after AHCC using enzyme-linked immunosorbent assay (ELISA).
additional nutritional effect- WAZ score
changes in weight-for-age z-score as sign of growth and nutritional status.
additional nutritional effect- Weight in gram
changes in weight in gram as sign of growth and nutritional status.
additional nutritional effect- HAZ score
changes in height-for-age z-score as sign of growth and nutritional status.
compliance and adherence rates
evaluate compliance and adherence rates to the intervention and their association with study outcomes. The secondary outcome measures include: * The count of days missed from Daycare Centers due to symptoms of the common cold symptoms * The duration of fever and cough during viral infections * Any side effects linked to the consumption of AHCC.
Caregiver-reported adherence
Adherence monitored through daily intake logs, home visits, and telephone follow-ups
Incidence of adverse events
Adverse events data collection during and post intervention
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Hasanuddin University
Lead sponsor
Amino Up Co. Ltd., Sapporo, Japan
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
