Immune FunctionNCT07853573
Effects of TM02® Supplementation on Immune Function in Children
A study testing TM02® in people with Immune Function and Immunity, run by Ligno Biotech Sdn. Bhd. at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Function, Immunity
- What is being tested?
- TM02®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Genetic disorders.
- Autoimmune diseases.
- Chronic diseases.
- Anemia.
- Immune dysfunction.
- Known allergy to mushrooms.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beneficial Effects of TM02® Supplementation in Improving Immunity Among Children: A Randomized, Double-Blind, Placebo-Controlled Trial
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.
Read the detailed description
TM02® is a Tiger Milk Mushroom (Lignosus rhinocerus) supplement developed for oral supplementation. This prospective, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy of TM02® supplementation in modulating immune-related outcomes among generally healthy children aged 2 to 12 years.
Block randomization using blocks of four was performed. The randomization sequence was generated using a computer-based random number generator by an independent statistician who was not involved in participant enrollment. Allocation concealment was implemented using sequentially numbered, opaque, sealed envelopes. Participants and investigators were blinded to treatment allocation.
Participants assigned to the intervention group received one chewable tablet containing 125 mg TM02® twice daily, corresponding to a total daily intake of 250 mg, for 12 weeks. Participants assigned to the placebo group received a matching chewable tablet containing the same excipients but without TM02®.
Study assessments were performed at baseline (Week 0) and at Weeks 4, 8, and 12. Unstimulated saliva samples were collected using a passive-drool method and immune biomarkers were quantified using ELISA. The assessed salivary biomarkers comprised IgA, IL-2, IL-6, and TNF-α. Immune-related health status was assessed using the Immune Status Questionnaire and a 10-point Visual Analogue Scale.
Safety was monitored throughout the 12-week intervention period. Participants and their guardians were instructed to report any adverse event or serious adverse event to the research team.
- Conditions
- Immune Function, Immunity
- Being tested
- TM02®, Placebo
- Keywords
- Tiger Milk Mushroom, Lignosus rhinocerus, Immune function, Mucosal immunity, Salivary IgA, Interleukin-2, Interleukin-6, TNF-alpha, Children, Nutritional supplementation, Respiratory health, TM02
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary supplement
Matching chewable placebo containing the same excipients as the intervention product but without TM02®. Participants consumed one tablet twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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®. Receives: 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®. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Jun 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immune FunctionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligno Biotech Sdn. Bhd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UCSI University
- Responsible party
- Sponsor
- Investigators
- Chung Keat Tan, PhD, Principal investigator, UCSI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853573
- Sponsor's protocol ID
- IEC-2025-FMHS-0009
- Other IDs
- NMRR ID-25-00677-SNR
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data sharing plan has not yet been finalized. Any future sharing of de-identified participant data will be subject to approval by the study sponsor and consideration of applicable ethical, confidentiality, and data protection requirements.
Publications
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.
PubMed 25256382Tan 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.
PubMed 34083710
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of TM02® Supplementation in Improving Immunity Among Children: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07853573
- Acronym / sponsor ID
- IEC-2025-FMHS-0009
- Conditions
- Immune Function, Immunity
- Keywords
- Tiger Milk Mushroom, Lignosus rhinocerus, Immune function, Mucosal immunity, Salivary IgA, Interleukin-2, Interleukin-6, TNF-alpha
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ligno Biotech Sdn. Bhd.Industry (pharma, biotech, devices)
- Collaborators
- UCSI University
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TM02® is a Tiger Milk Mushroom (Lignosus rhinocerus) supplement developed for oral supplementation. This prospective, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy of TM02® supplementation in modulating immune-related outcomes among generally healthy children aged 2 to 12 years.
Block randomization using blocks of four was performed. The randomization sequence was generated using a computer-based random number generator by an independent statistician who was not involved in participant enrollment. Allocation concealment was implemented using sequentially numbered, opaque, sealed envelopes. Participants and investigators were blinded to treatment allocation.
Participants assigned to the intervention group received one chewable tablet containing 125 mg TM02® twice daily, corresponding to a total daily intake of 250 mg, for 12 weeks. Participants assigned to the placebo group received a matching chewable tablet containing the same excipients but without TM02®.
Study assessments were performed at baseline (Week 0) and at Weeks 4, 8, and 12. Unstimulated saliva samples were collected using a passive-drool method and immune biomarkers were quantified using ELISA. The assessed salivary biomarkers comprised IgA, IL-2, IL-6, and TNF-α. Immune-related health status was assessed using the Immune Status Questionnaire and a 10-point Visual Analogue Scale.
Safety was monitored throughout the 12-week intervention period. Participants and their guardians were instructed to report any adverse event or serious adverse event to the research team.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TM02® Supplementation | Experimental | Dietary Supplement: TM02®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®. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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®. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- Genetic disorders.
- Autoimmune diseases.
- Chronic diseases.
- Anemia.
- Immune dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TM02®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. | Dietary supplement | TM02® Supplementation |
| PlaceboMatching chewable placebo containing the same excipients as the intervention product but without TM02®. Participants consumed one tablet twice daily for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Change in Salivary Immunoglobulin A (IgA) Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
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.
Change in Salivary Interleukin-2 (IL-2) Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
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.
Change in Salivary Interleukin-6 (IL-6) Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
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.
Change in Salivary Tumor Necrosis Factor-alpha (TNF-α) Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
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.
Change in Immune Status Questionnaire (ISQ) Score
Time frame: Baseline, Week 4, Week 8, and Week 12
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.
Change in Visual Analogue Scale (VAS) Score for Perceived Immune Status
Time frame: Baseline, Week 4, Week 8, and Week 12
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 25256382Lee 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.
- Background: PubMed 34083710Tan 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.
- Individual participant dataSharing planned: Undecided. The individual participant data sharing plan has not yet been finalized. Any future sharing of de-identified participant data will be subject to approval by the study sponsor and consideration of applicable ethical, confidentiality, and data protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung Keat Tan, PhD principal investigator
UCSI University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TM02® in people with Immune Function and Immunity, run by Ligno Biotech Sdn. Bhd. at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Salivary Immunoglobulin A (IgA) Concentration (time frame: Baseline, Week 4, Week 8, and Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07853573, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.