Prevention With Ismigen of RTIs in Kids

Although the efficacy of PMBL® sublingual tablets is evident to most prescribers, the clinical studies available to demonstrate the efficacy of this bacterial lysate in preventing recurrent respiratory tract infections have undeniable methodological biases. To demonstrate the efficacy of PMBL® in the pediatric population without questionable bias, a randomized double-blind Placebo-controlled study will be conducted: one arm of children presenting with a risk of recurrent respiratory tract infections will be treated with PMBL® for a 3-month period, 10 days per months during the fall-winter whereas subjects of the Placebo arm will receive sublingual tablet indistinguishable from PMBL® but without active ingredients. Both groups of subjects will be followed for four additional months. To improve the accuracy of data and the tracking of respiratory tract infections (RTI), a diary will be provided to each subject, allowing them to report the event as soon as it occurs. If necessary, a visit may be planned to enable the investigator to assess the event accurately.

NCT Number	NCT07578012
Lead Sponsor	Lallemand Pharma AG
Conditions	Respiratory Tract Infections (RTI), Healthy Children
Enrollment	224 participants
Start Date	2026-06-01
Primary Completion	2027-03 (estimated)
Study Completion	2027-04 (estimated)
Updated on ClinicalTrials.gov	2026-07-08