Respiratory Tract Infections (RTI)Phase 4NCT07479394
Impact of AHCC® Supplementation for Prevention of Respiratory Tract Infections Among Children Age 4-6 Years Old
A Phase 4 study testing a prebiotic, that us a standardized extract of cultured Lentinula edodes mycelia in people with Respiratory Tract Infections (RTI), run by Hasanuddin University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections (RTI)
- What is being tested?
- a prebiotic, that us a standardized extract of cultured Lentinula edodes mycelia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 28 Feb 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Tract Infections (RTI)
- Being tested
- a prebiotic, that us a standardized extract of cultured Lentinula edodes mycelia, Placebo (dextrin)
- Keywords
- AHCC, Lentinula edodes mycelia, prebiotic, respiratory tract infection (RTI)
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a prebiotic, that us a standardized extract of cultured Lentinula edodes myceliaDietary supplement
Also called AHCC
Subjects will be administered dextrin including AHCC.
Placebo (dextrin)Dietary supplement
Subjects will be administered dextrin alone (placebo)
| Study group | Role | What they receive |
|---|---|---|
| Control arm of the intervention study | Placebo comparator | This is the control arm of the intervention study. Subjects will be administered dextrin alone (placebo) Receives: 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. Receives: Dietary Supplement: a prebiotic, that us a standardized extract of cultured Lentinula edodes mycelia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (7)
additional immunological effects
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).
Measured: 3 months
additional nutritional effect- WAZ score
changes in weight-for-age z-score as sign of growth and nutritional status.
Measured: 3 months
additional nutritional effect- Weight in gram
changes in weight in gram as sign of growth and nutritional status.
Measured: 3 months
additional nutritional effect- HAZ score
changes in height-for-age z-score as sign of growth and nutritional status.
Measured: 3 months
additional nutritional effect- Height in cm
changes in height in cm as sign of growth and nutritional status.
Measured: 3 months
additional nutritional effect- WHZ score
changes in weight-for-height z-score as sign of growth and nutritional status.
Measured: 3 months
additional nutritional effect- Head circumference in cm
changes in head circumference in cm as sign of growth and nutritional status.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start15 Aug 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract Infections (RTI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Collaborators
- Amino Up Co. Ltd., Sapporo, Japan
- Responsible party
- Principal investigator, Conny Tanjung, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479394
- Sponsor's protocol ID
- ID01/UNHAS/March/2026
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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-pulmonary-tuberculosis-patients
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.
PubMed 26788109Hong 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.
PubMed 32141233Imdad 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.
PubMed 36994923Berthon 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.
PubMed 35481594Hong 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.
PubMed 40100227Madolangan 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.
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.
PubMed 31930148Di 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.
PubMed 32162896Rennerova Z, Pico Sirvent L, Carvajal Roca E, Pasnik J, Logar M, Milosevic K, Majtan J, Jesenak M. Beta-(1,3/1,6)-D-glucan from Pleurotus ostreatus in the prevention of recurrent respiratory tract infections: An international, multicentre, open-label, prospective study. Front Pediatr. 2022 Oct 14;10:999701. doi: 10.3389/fped.2022.999701. eCollection 2022.
PubMed 36324817Loosen SH, Plendl W, Konrad M, Tanislav C, Luedde T, Roderburg C, Kostev K. Prevalence of Upper Respiratory Tract Infections Before, During, and After the COVID-19 Pandemic in Germany: A Cross-Sectional Study of 2 167 453 Outpatients. J Prim Care Community Health. 2023 Jan-Dec;14:21501319231204436. doi: 10.1177/21501319231204436.
PubMed 37846103Hishiki H, Kawashima T, Tsuji NM, Ikari N, Takemura R, Kido H, Shimojo N. A Double-Blind, Randomized, Placebo-Controlled Trial of Heat-Killed Pediococcus acidilactici K15 for Prevention of Respiratory Tract Infections among Preschool Children. Nutrients. 2020 Jul 3;12(7):1989. doi: 10.3390/nu12071989.
PubMed 32635408Falsaperla R, Sortino V, La Cognata D, Barberi C, Corsello G, Malaventura C, Suppiej A, Collotta AD, Polizzi A, Grassi P, Ruggieri M. Acute Respiratory Tract Infections (ARTIs) in Children after COVID-19-Related Social Distancing: An Epidemiological Study in a Single Center of Southern Italy. Diagnostics (Basel). 2024 Jun 25;14(13):1341. doi: 10.3390/diagnostics14131341.
PubMed 39001232