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Prevention With Ismigen of RTIs in Kids
Sponsor: Lallemand Pharma AG
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.
Official title: A Randomized Double-blind Placebo-controlled Study to Demonstrate the Efficacy of PMBL® Sublingual Tablets in Reducing the Incidence of Respiratory Tract Infections in Children Aged 3-12 Years (PIRTIK).
Key Details
Gender
All
Age Range
3 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
224
Start Date
2026-06-01
Completion Date
2027-04
Last Updated
2026-07-08
Healthy Volunteers
Yes
Interventions
Bacterial Lysates
3-month period, 10 days per months during the fall-winter
Placebo
3-month period, 10 days per months during the fall-winter
Locations (10)
Bio Zdrowie
Bialystok, Poland
In Vivo Sp. z o.o.
Bydgoszcz, Poland
Vitamed
Bydgoszcz, Poland
Centrum Nowoczesnych Terapii
Krakow, Poland
Comarch Healthcare S.A.
Krakow, Poland
Linden Sp. z o.o. sp.k.
Krakow, Poland
Allergotest
Lublin, Poland
Medicome Sp. z o.o.
Oświęcim, Poland
Med - Polonia
Poznan, Poland
Alergo-Med Specjalistyczna Przychodnia
Tarnów, Poland