Effects of TM02® Supplementation on Immune Function in Children

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.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.