Prevention With Ismigen of RTIs in Kids

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Respiratory Tract Infections (RTI), Healthy Children

In brief

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.

Key facts

Study ID: NCT07578012
Run by: Lallemand Pharma AG
People needed: 224
Starts: 2026-06-01
Expected to finish: 2027-04-01
Last updated by the study team: 2026-07-08

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.
Pregnant/Lactating female or with sexual activity without hormonal contraception, intrauterine device or barrier methods.
Primary or secondary immunodeficiency, cystic fibrosis, bronchiectasis, alpha-1 antitrypsin deficiency, malignancy, endocrinological diseases or other chronic respiratory diseases, except asthma and allergic rhinitis.
Known sensitivity to the components of study medication.
Any major surgery within the last 3 months prior to study enrolment or planned to occur within the duration of study.
Treatment with the following medications:
Injection or oral administration of steroids within 4 weeks prior to study enrolment.
Previous and/or concomitant immunosuppressants, immunostimulants, allergen-immunotherapy or gamma globulins within 6 months prior to study enrolment.
Inability to understand or comply with study procedures or with study treatment intake.
Subject participating in another interventional clinical study at the time of screening visit.

Where it is running

Alergo-Med Specjalistyczna Przychodnia — Tarnów, Poland (enrolling)
In Vivo Sp. z o.o. — Bydgoszcz, Poland (enrolling)
Vitamed — Bydgoszcz, Poland (enrolling)
Centrum Nowoczesnych Terapii — Krakow, Poland (enrolling)
Bio Zdrowie — Bialystok, Poland (enrolling)
Linden Sp. z o.o. sp.k. — Krakow, Poland (enrolling)
Allergotest — Lublin, Poland (enrolling)
Medicome Sp. z o.o. — Oświęcim, Poland (enrolling)
Med - Polonia — Poznan, Poland (enrolling)
Comarch Healthcare S.A. — Krakow, Poland

Full record on ClinicalTrials.gov

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