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

March 16, 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 2-4 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

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • 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

  • Name: Conny Tanjung, 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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Children aged 2-4 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
Intervention / Treatment
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

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

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

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

Collaborators and Investigators

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

Sponsor

Hasanuddin University

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)

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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