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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003912', 'term': 'Dextrins'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'compliance and adherence rates', 'timeFrame': '3 months', 'description': 'evaluate compliance and adherence rates to the intervention and their association with study outcomes. The secondary outcome measures include:\n\n* The count of days missed from Daycare Centers due to symptoms of the common cold symptoms\n* The duration of fever and cough during viral infections\n* Any side effects linked to the consumption of AHCC.'}, {'measure': 'Caregiver-reported adherence', 'timeFrame': '3 months', 'description': 'Adherence monitored through daily intake logs, home visits, and telephone follow-ups'}], 'primaryOutcomes': [{'measure': 'Incidence of Respiratory Tract Infection', 'timeFrame': '3 months', 'description': 'the number incidence of infections, specifically respiratory tract infection, by looking at the number of febrile days (\\>37.5 ◦C) during the test period.'}], 'secondaryOutcomes': [{'measure': 'additional immunological effects', 'timeFrame': '3 months', 'description': '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).'}, {'measure': 'additional nutritional effect- WAZ score', 'timeFrame': '3 months', 'description': 'changes in weight-for-age z-score as sign of growth and nutritional status.'}, {'measure': 'additional nutritional effect- Weight in gram', 'timeFrame': '3 months', 'description': 'changes in weight in gram as sign of growth and nutritional status.'}, {'measure': 'additional nutritional effect- HAZ score', 'timeFrame': '3 months', 'description': 'changes in height-for-age z-score as sign of growth and nutritional status.'}, {'measure': 'additional nutritional effect- Height in cm', 'timeFrame': '3 months', 'description': 'changes in height in cm as sign of growth and nutritional status.'}, {'measure': 'additional nutritional effect- WHZ score', 'timeFrame': '3 months', 'description': 'changes in weight-for-height z-score as sign of growth and nutritional status.'}, {'measure': 'additional nutritional effect- Head circumference in cm', 'timeFrame': '3 months', 'description': 'changes in head circumference in cm as sign of growth and nutritional status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AHCC', 'Lentinula edodes mycelia', 'prebiotic', 'respiratory tract infection (RTI)'], 'conditions': ['Respiratory Tract Infections (RTI)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '26788109', 'type': 'BACKGROUND', 'citation': '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': '32141233', 'type': 'BACKGROUND', 'citation': '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': '36994923', 'type': 'BACKGROUND', 'citation': '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': '35481594', 'type': 'BACKGROUND', 'citation': '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': '40100227', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31930148', 'type': 'BACKGROUND', 'citation': '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': '32162896', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36324817', 'type': 'BACKGROUND', 'citation': 'Rennerova 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.'}, {'pmid': '37846103', 'type': 'BACKGROUND', 'citation': 'Loosen 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.'}, {'pmid': '32635408', 'type': 'BACKGROUND', 'citation': 'Hishiki 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.'}, {'pmid': '39001232', 'type': 'BACKGROUND', 'citation': 'Falsaperla 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.'}, {'pmid': '38356949', 'type': 'BACKGROUND', 'citation': 'Chan CM, Wahab AA, Ali A. Assessing the impact of COVID-19 on epidemiological changes of severe pediatric respiratory syncytial virus infections in Malaysia. Front Public Health. 2024 Jan 31;12:1246921. doi: 10.3389/fpubh.2024.1246921. eCollection 2024.'}, {'pmid': '23351405', 'type': 'BACKGROUND', 'citation': 'Roman BE, Beli E, Duriancik DM, Gardner EM. Short-term supplementation with active hexose correlated compound improves the antibody response to influenza B vaccine. Nutr Res. 2013 Jan;33(1):12-7. doi: 10.1016/j.nutres.2012.11.001. Epub 2012 Dec 4.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children aged 2-4 years old at the time of enrolment\n2. Good nutritional status with weight-for-height \\> -2, and height-for-age z-score \\> -2 based on WHO growth standards\n3. Infants in a group setting (daycare centers).\n4. No congenital disorder\n5. Not suffering from severe coughing or diarrhoea at the time of recruitment\n6. Written informed consent will be obtained from parents or legal guardians before enrollment.\n\nExclusion Criteria:\n\n* Presence of chronic illnesses or conditions (congenital disorder, genetic syndromes, congenital heart disease, chronic renal failure, cystic fibrosis, etc)\n* Children who have participated in another clinical intervention study within the past 30 days.\n* Children who are likely to be transferred to another facility that is not part of the study before completing the follow-up period'}, 'identificationModule': {'nctId': 'NCT07479394', 'briefTitle': 'Impact of AHCC® Supplementation for Prevention of Respiratory Tract Infections Among Children Age 2-4 Years Old', 'organization': {'class': 'OTHER', 'fullName': 'Hasanuddin University'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled Trial of AHCC® Supplementation for Prevention of Respiratory Tract Infections Among Children Age 2-4 Years Old', 'orgStudyIdInfo': {'id': 'ID01/UNHAS/March/2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm of the intervention study', 'description': 'This is the control arm of the intervention study. Subjects will be administered dextrin alone (placebo)', 'interventionNames': ['Dietary Supplement: Placebo (dextrin)']}, {'type': 'OTHER', 'label': 'Active arm of the intervention study', 'description': 'This is the active arm of the intervention study.Subjects will be administered dextrin including AHCC.', 'interventionNames': ['Dietary Supplement: a prebiotic, that us a standardized extract of cultured Lentinula edodes mycelia']}], 'interventions': [{'name': 'a prebiotic, that us a standardized extract of cultured Lentinula edodes mycelia', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['AHCC'], 'description': 'Subjects will be administered dextrin including AHCC.', 'armGroupLabels': ['Active arm of the intervention study']}, {'name': 'Placebo (dextrin)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will be administered dextrin alone (placebo)', 'armGroupLabels': ['Control arm of the intervention study']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Conny Tanjung, PhD; Consultant Pediatrician', 'role': 'CONTACT', 'email': 'conny.tanj@gmail.com', 'phone': '+6281282733388'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasanuddin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Conny Tanjung', 'investigatorAffiliation': 'Hasanuddin University'}}}}