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

NCT07479394 | Not Yet Recruiting Phase 4

• 1 other identifier: ID01/UNHAS/March/2026
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Tract Infections (RTI)

Keywords

AHCC; Lentinula edodes mycelia; prebiotic; respiratory tract infection (RTI)

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (7)

• additional immunological effects

  3 months

• additional nutritional effect- WAZ score

  3 months

• additional nutritional effect- Weight in gram

  3 months

• additional nutritional effect- HAZ score

  3 months

• additional nutritional effect- Height in cm

  3 months

Other Outcomes (2)

• compliance and adherence rates

  3 months

• Caregiver-reported adherence

  3 months

Study Arms (2)

Control arm of the intervention study

PLACEBO COMPARATOR

This is the control arm of the intervention study. Subjects will be administered dextrin alone (placebo)

Dietary Supplement: Placebo (dextrin)

Active arm of the intervention study

OTHER

This is the active arm of the intervention study.Subjects will be administered dextrin including AHCC.

Dietary Supplement: a prebiotic, that us a standardized extract of cultured Lentinula edodes mycelia

Interventions

a prebiotic, that us a standardized extract of cultured Lentinula edodes mycelia DIETARY_SUPPLEMENT

Subjects will be administered dextrin including AHCC.

Also known as: AHCC

Active arm of the intervention study

Placebo (dextrin) DIETARY_SUPPLEMENT

Subjects will be administered dextrin alone (placebo)

Control arm of the intervention study

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 2-4 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasanuddin University: lead

Related Publications (17)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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-pulmonary-tuberculosis-patients

  BACKGROUND

• 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 BACKGROUND

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  PMID: 32141233 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Madolangan J, Yusuf I, Djaharuddin I, Wahyudin E, Bukhari A. The Active Hexose Correlated Compound (AHCC ® ) Effect on Clinical Outcome of Pulmonary Tuberculosis in HIV-Infected Patients. Vol. 44. 2021.

  BACKGROUND

• Shin MS, Park HJ, Maeda T, Nishioka H, Fujii H, Kang I. The Effects of AHCC(R), a Standardized Extract of Cultured Lentinura edodes Mycelia, on Natural Killer and T Cells in Health and Disease: Reviews on Human and Animal Studies. J Immunol Res. 2019 Dec 20;2019:3758576. doi: 10.1155/2019/3758576. eCollection 2019.

  PMID: 31930148 BACKGROUND

• Di Pierro F, Bertuccioli A, Cavecchia I. Possible therapeutic role of a highly standardized mixture of active compounds derived from cultured Lentinula edodes mycelia (AHCC) in patients infected with 2019 novel coronavirus. Minerva Gastroenterol Dietol. 2020 Jun;66(2):172-176. doi: 10.23736/S1121-421X.20.02697-5. Epub 2020 Mar 12.

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  PMID: 23351405 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Dextrins

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Central Study Contacts

Conny Tanjung, PhD; Consultant Pediatrician

CONTACT

+6281282733388; conny.tanj@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 18, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03