Impact of AHCC® Supplementation for Prevention of Respiratory Tract Infections Among Children Age 4-6 Years Old

Official title

A Double-Blind, Randomized, Placebo-Controlled Trial of AHCC® Supplementation for Prevention of Respiratory Tract Infections Among Children Age 4-6 Years Old

Overview

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 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)

Primary outcome measures

• Incidence of Respiratory Tract Infection [Time frame: 3 months]

Secondary outcome measures (7)

• additional immunological effects [Time frame: 3 months]
• additional nutritional effect- WAZ score [Time frame: 3 months]
• additional nutritional effect- Weight in gram [Time frame: 3 months]
• additional nutritional effect- HAZ score [Time frame: 3 months]
• additional nutritional effect- Height in cm [Time frame: 3 months]
• additional nutritional effect- WHZ score [Time frame: 3 months]
• additional nutritional effect- Head circumference in cm [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

• 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
• Not suffering from severe coughing or diarrhoea at the time of recruitment
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Ishizuka R, Fujii H, Miura T, Fukuchi Y, Tajima K. Personalized cancer therapy for stage IV non-small cell lung cancer: Combined use of active hexose correlated compound and genistein concentrated polysaccharide. Personalized Medicine Universe. 2012 Jul;1(1):39-44.
• Parida DK, Wakame K, Nomura T. Integrating Complimentary and Alternative Medicine in Form of Active Hexose Co-Related Compound (AHCC) in the Management of Head & Neck Cancer Patients. Int J Clin Med. 2011;02(05):588-92.
• Madolangan J, Djaharuddin I, Yusuf I, Wahyudin E, Bukhari A. THE EFFECT OF ACTIVE HEXOSE CORRELATED COMPOUND (AHCC ® ) ON LEVELS OF CD4+ AND CD8+ LYMPHOCYTE IN PULMONARY TUBERCULOSIS PATIENTS [Internet]. Vol. 44. 2021 [cited 2025 Feb 28]. Available from: https://www.teikyomedicaljournal.com/article/the-effect-of-active-hexose-correlated-compound-ahcc-on-levels-of-cd4-and-cd8-lymphocyte-in-pulmonar
• Olamigoke L, Mansoor E, Mann V, Ellis I, Okoro E, Wakame K, Fuji H, Kulkarni A, Francoise Doursout M, Sundaresan A. AHCC Activation and Selection of Human Lymphocytes via Genotypic and Phenotypic Changes to an Adherent Cell Type: A Possible Novel Mechanism of T Cell Activation. Evid Based Complement Alternat Med. 2015;2015:508746. doi: 10.1155/2015/508746. Epub 2015 Dec 15. PMID 26788109
• Hong M, Xiong T, Huang J, Wu Y, Lin L, Zhang Z, Huang L, Gao D, Wang H, Kang C, Gao Q, Yang X, Yang N, Hao L. Association of vitamin D supplementation with respiratory tract infection in infants. Matern Child Nutr. 2020 Jul;16(3):e12987. doi: 10.1111/mcn.12987. Epub 2020 Mar 5. PMID 32141233
• Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3. PMID 36994923
• Berthon BS, Williams LM, Williams EJ, Wood LG. Effect of Lactoferrin Supplementation on Inflammation, Immune Function, and Prevention of Respiratory Tract Infections in Humans: A Systematic Review and Meta-analysis. Adv Nutr. 2022 Oct 2;13(5):1799-1819. doi: 10.1093/advances/nmac047. PMID 35481594
• Hong BV, Al-Dashti YA, Charoenwoodhipong P, Zivkovic AM, Hackman RM. Identification and Quantification of alpha-D-Glucopyranosyl-Isomaltol, alpha-D-Maltosyl-Isomaltol, and alpha-Glucan in AHCCW Cultured Mushroom Mycelia Extract. Int J Med Mushrooms. 2025;27(6):1-11. doi: 10.1615/IntJMedMushrooms.2025058247. PMID 40100227

Identifiers

NCT: NCT07479394 · ID01/UNHAS/March/2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗