Respiratory Tract Infections (RTI)
Conditions
Keywords
AHCC, Lentinula edodes mycelia, prebiotic, respiratory tract infection (RTI)
Brief summary
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.
Detailed description
A three-month, randomized, double-blind, placebo-controlled, pilot study will be performed in Indonesian healthy children aged 4 to 6 years in Nursery Schools. Subjects will be administered dextrin alone (placebo) or dextrin including AHCC. The incidence of RTI will be the primary outcome, and changes in serum Interferon Gamma (IFN-γ) as the crucial cytokine that acts as anti infective in the immune system will be the secondary outcome. Following completion of the 3 months intervention, participants will enter a 5 months follow up period (Months 4-8). New onset adverse events, ongoing adverse events, serious adverse events, and investigator assessed intervention related adverse events will be collected and evaluated.
Interventions
DIETARY_SUPPLEMENTa prebiotic, that us a standardized extract of cultured Lentinula edodes mycelia
Subjects will be administered dextrin including AHCC.
DIETARY_SUPPLEMENTPlacebo (dextrin)
Subjects will be administered dextrin alone (placebo)
Sponsors
Hasanuddin University
Amino Up Co. Ltd., Sapporo, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A three-month, randomized, double-blind, placebo-controlled, pilot study will be performed in Indonesian healthy children aged 4 to 6 years in Nursery Schools. Children will be monitored for adverse events for 5 months following completion of the 3 months intervention
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
1. Children aged 4-6 years old at the time of enrolment 2. Good nutritional status with weight-for-height \> -2, and height-for-age z-score \> -2 based on WHO growth standards 3. Infants in a group setting (daycare centers). 4. No congenital disorder 5. Not suffering from severe coughing or diarrhoea at the time of recruitment 6. Written informed consent will be obtained from parents or legal guardians before enrollment.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Respiratory Tract Infection | 3 months | the number incidence of infections, specifically respiratory tract infection, by looking at the number of febrile days (\>37.5 ◦C) during the test period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| additional immunological effects | 3 months | 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 | 3 months | changes in weight-for-age z-score as sign of growth and nutritional status. |
| additional nutritional effect- Weight in gram | 3 months | changes in weight in gram as sign of growth and nutritional status. |
| additional nutritional effect- HAZ score | 3 months | changes in height-for-age z-score as sign of growth and nutritional status. |
| additional nutritional effect- Height in cm | 3 months | changes in height in cm as sign of growth and nutritional status. |
| additional nutritional effect- WHZ score | 3 months | changes in weight-for-height z-score as sign of growth and nutritional status. |
| additional nutritional effect- Head circumference in cm | 3 months | changes in head circumference in cm as sign of growth and nutritional status. |
Contacts
CONTACTConny Tanjung, MD,PhD;Consultant Pediatrician
Outcome results
None listed