NCT07479394

Impact of AHCC® Supplementation for Prevention of Respiratory Tract Infections Among Children Age 2-4 Years Old

A Double-Blind, Randomized, Placebo-Controlled Trial of AHCC® Supplementation for Prevention of Respiratory Tract Infections Among Children Age 2-4 Years Old

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hasanuddin University · Academic / Other
• Sex: All
• Age: 2 Years – 4 Years
• Healthy volunteers: Accepted

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 2 to 4 years in Daycare Centers. 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.

Conditions

• Respiratory Tract Infections (RTI)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	a prebiotic, that us a standardized extract of cultured Lentinula edodes mycelia	Subjects will be administered dextrin including AHCC.
DIETARY_SUPPLEMENT	Placebo (dextrin)	Subjects will be administered dextrin alone (placebo)

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-03-18
• Last updated: 2026-03-18