Effects of TM02® Supplementation on Immune Function in Children

NCT07853573 | Completed

• 2 other identifiers: IEC-2025-FMHS-0009NMRR ID-25-00677-SNR
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, placebo-controlled clinical study evaluated the effects of 12 weeks of TM02® supplementation on immune-related outcomes in generally healthy children aged 2 to 12 years. Participants were randomized to receive either TM02® or a matching placebo for 12 weeks. Immune-related assessments were performed at baseline and at Weeks 4, 8, and 12. Outcomes included salivary immunoglobulin A (IgA), interleukin-2 (IL-2), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), the Immune Status Questionnaire (ISQ), and Visual Analogue Scale (VAS) for immunity status, when participants experienced illness. Safety and tolerability were monitored throughout the study.

Conditions

Immune Function; Immunity

Keywords

Tiger Milk Mushroom; Lignosus rhinocerus; Immune function; Mucosal immunity; Salivary IgA; Interleukin-2; Interleukin-6; TNF-alpha; Children; Nutritional supplementation; Respiratory health; TM02

Outcome Measures

Primary Outcomes (6)

• Change in Salivary Immunoglobulin A (IgA) Concentration

  Unstimulated salivary IgA concentration was quantified using an enzyme-linked immunosorbent assay (ELISA) and expressed in ng/mL. Changes in salivary IgA concentrations over the 12-week intervention period were assessed between the TM02® and placebo groups.

  Baseline, Week 4, Week 8, and Week 12

• Change in Salivary Interleukin-2 (IL-2) Concentration

  Unstimulated salivary IL-2 concentration was quantified using ELISA and expressed in pg/mL. Changes over the 12-week intervention period were assessed between the TM02® and placebo groups.

  Baseline, Week 4, Week 8, and Week 12

• Change in Salivary Interleukin-6 (IL-6) Concentration

  Unstimulated salivary IL-6 concentration was quantified using ELISA and expressed in pg/mL. Changes over the 12-week intervention period were assessed between the TM02® and placebo groups.

  Baseline, Week 4, Week 8, and Week 12

• Change in Salivary Tumor Necrosis Factor-alpha (TNF-α) Concentration

  Unstimulated salivary TNF-α concentration was quantified using ELISA and expressed in pg/mL. Changes over the 12-week intervention period were assessed between the TM02® and placebo groups.

  Baseline, Week 4, Week 8, and Week 12

• Change in Immune Status Questionnaire (ISQ) Score

  The Immune Status Questionnaire (ISQ) consists of seven items assessing the frequency of immune-related complaints, including common cold, diarrhea, sudden high fever, headache, muscle and joint pain, skin problems, and coughing. Each item is scored from 0 (never) to 4 ((almost) always), giving a raw total score ranging from 0 to 28. A lower total score indicates fewer immune-related complaints and better perceived immune status, whereas a higher score indicates more frequent immune-related complaints and poorer perceived immune status. Changes in raw ISQ scores over the 12-week intervention period were compared between the TM02® and placebo groups.

  Baseline, Week 4, Week 8, and Week 12

• Change in Visual Analogue Scale (VAS) Score for Perceived Immune Status

  Perceived immune status was assessed using a Visual Analogue Scale ranging from 0 to 10, where 0 represents very poor perceived immune status and 10 represents excellent perceived immune status. Higher scores indicate better perceived immune status. Changes in VAS scores over the 12-week intervention period were compared between the TM02® and placebo groups.

  Baseline, Week 4, Week 8, and Week 12

Study Arms (2)

TM02® Supplementation

EXPERIMENTAL

Participants received one TM02® chewable tablet containing 125 mg of Tiger Milk Mushroom twice daily for 12 weeks, corresponding to a total daily dose of 250 mg TM02®.

Dietary Supplement: TM02®

Placebo

PLACEBO COMPARATOR

Participants received one matching placebo chewable tablet twice daily for 12 weeks. The placebo was matched in appearance and formulation to the TM02® tablet but did not contain TM02®.

Dietary Supplement: Placebo

Interventions

TM02® DIETARY_SUPPLEMENT

TM02® was provided as a chewable tablet containing 125 mg Tiger Milk Mushroom together with mixed berry juice powder and other excipients. Participants consumed one tablet twice daily for 12 weeks, providing a total daily TM02® dose of 250 mg.

TM02® Supplementation

Placebo DIETARY_SUPPLEMENT

Matching chewable placebo containing the same excipients as the intervention product but without TM02®. Participants consumed one tablet twice daily for 12 weeks.

Placebo

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Generally healthy participants.
• Aged 2 to 12 years.
• Willing and able to comply with the intervention plan and attend scheduled follow-up assessments.
• Written informed consent provided by a parent or legal guardian.
• Parent or legal guardian able to comprehend English.

You may not qualify if:

• Genetic disorders.
• Autoimmune diseases.
• Chronic diseases.
• Anemia.
• Immune dysfunction.
• Known allergy to mushrooms.
• History of severe environmental allergies requiring medication or allergy shots.
• History or presence of a clinically relevant cardiac, renal, hepatic, endocrine, pulmonary, biliary, gastrointestinal, or pancreatic disorder, or any other condition that could adversely affect the participant's ability to complete the study.
• Small size at birth or preterm birth before 37 weeks of gestation.
• Use of immunosuppressive medication
• Use of supplements targeting immunity within the previous 30 days.

Sponsors & Collaborators

• Ligno Biotech Sdn. Bhd.: lead
• UCSI University: collaborator

Study Sites (1)

UCSI University

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (2)

• Lee SS, Tan NH, Fung SY, Sim SM, Tan CS, Ng ST. Anti-inflammatory effect of the sclerotium of Lignosus rhinocerotis (Cooke) Ryvarden, the Tiger Milk mushroom. BMC Complement Altern Med. 2014 Sep 25;14:359. doi: 10.1186/1472-6882-14-359.

  PMID: 25256382 BACKGROUND

• Tan ESS, Leo TK, Tan CK. Effect of tiger milk mushroom (Lignosus rhinocerus) supplementation on respiratory health, immunity and antioxidant status: an open-label prospective study. Sci Rep. 2021 Jun 3;11(1):11781. doi: 10.1038/s41598-021-91256-6.

  PMID: 34083710 BACKGROUND

Study Officials

• Chung Keat Tan, PhD

  UCSI University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants were assigned in parallel to either TM02® supplementation or matching placebo for 12 weeks. Block randomization with blocks of four was performed using a computer-generated randomization sequence prepared by an independent statistician. Allocation was concealed using sequentially numbered, opaque, sealed envelopes.

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 2, 2026
• Study Start: June 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

MY (1)