Prevention With Ismigen of RTIs in Kids (NCT07578012) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Prevention With Ismigen of RTIs in Kids
Poland224 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range3 Years – 12 Years
SexALL
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Inclusion criteria
✓. Children of both genders aged from 3 to 12 years.
✓. Written informed consent obtained from the parents/legally authorized representatives
✓. Written assent obtained from the subject from 7 years
✓. Subject presenting with a susceptibility to respiratory tract infections according to the investigator
✓. No respiratory tract infection within 15 days before the randomization visit
✓. All girls of childbearing potential have a negative pregnancy urine testing at randomization visit and are informed and their parents as well of the requirement for contraception during the study.
✓. A cooperative attitude and ability to correct use of PMBL® tablet.
Exclusion criteria
✕. Subject treated with bacterial lysates within the previous 6 months prior to V1 or ongoing treatment.
✕. Body temperature ≥ 37.5°C at the randomization visit.
What they're measuring
1
The total number of RTIs experienced by each subject throughout the 7-month study period (3-month treatment + 4-month follow-up).
Timeframe: Throughout the 7-month study period (3-month treatment + 4-month follow-up).