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

July 9, 2026 updated by: Conny Tanjung, Hasanuddin University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Conny Tanjung, MD,PhD;Consultant Pediatrician
  • Phone Number: +6281282733388
  • Email: conny.tanj@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Children aged 4-6 years old at the time of enrolment
  2. Good nutritional status with weight-for-height > -2, and height-for-age z-score > -2 based on WHO growth standards
  3. Infants in a group setting (daycare centers).
  4. No congenital disorder
  5. Not suffering from severe coughing or diarrhoea at the time of recruitment
  6. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control arm of the intervention study
This is the control arm of the intervention study. Subjects will be administered dextrin alone (placebo)
Dietary supplement: Placebo (dextrin)
Subjects will be administered dextrin alone (placebo)
Other: Active arm of the intervention study
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
Subjects will be administered dextrin including AHCC.
Other Names:
  • AHCC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Respiratory Tract Infection
Time Frame: 3 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
additional immunological effects
Time Frame: 3 months
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).
3 months
additional nutritional effect- WAZ score
Time Frame: 3 months
changes in weight-for-age z-score as sign of growth and nutritional status.
3 months
additional nutritional effect- Weight in gram
Time Frame: 3 months
changes in weight in gram as sign of growth and nutritional status.
3 months
additional nutritional effect- HAZ score
Time Frame: 3 months
changes in height-for-age z-score as sign of growth and nutritional status.
3 months
additional nutritional effect- Height in cm
Time Frame: 3 months
changes in height in cm as sign of growth and nutritional status.
3 months
additional nutritional effect- WHZ score
Time Frame: 3 months
changes in weight-for-height z-score as sign of growth and nutritional status.
3 months
additional nutritional effect- Head circumference in cm
Time Frame: 3 months
changes in head circumference in cm as sign of growth and nutritional status.
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
compliance and adherence rates
Time Frame: 3 months

evaluate compliance and adherence rates to the intervention and their association with study outcomes. The secondary outcome measures include:

  • The count of days missed from Daycare Centers due to symptoms of the common cold symptoms
  • The duration of fever and cough during viral infections
  • Any side effects linked to the consumption of AHCC.
3 months
Caregiver-reported adherence
Time Frame: 3 months
Adherence monitored through daily intake logs, home visits, and telephone follow-ups
3 months
Incidence of adverse events
Time Frame: Baseline through Month 8 (including 5 months post intervention follow up)
Adverse events data collection during and post intervention
Baseline through Month 8 (including 5 months post intervention follow up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasanuddin University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Amino Up Co. Ltd., Sapporo, Japan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ID01/UNHAS/March/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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