Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:56 AM
Study NCT ID:
NCT07479394
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of AHCC® Supplementation for Prevention of Respiratory Tract Infections Among Children Age 2-4 Years Old
Sponsor:
Hasanuddin University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: