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RECRUITING
NCT07578012
PHASE4

Prevention With Ismigen of RTIs in Kids

Sponsor: Lallemand Pharma AG

View on ClinicalTrials.gov

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

DRUG

Bacterial Lysates

3-month period, 10 days per months during the fall-winter

DRUG

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