NCT07578012 Prevention With Ismigen of RTIs in Kids
| NCT ID | NCT07578012 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Lallemand Pharma AG |
| Condition | Respiratory Tract Infections (RTI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 224 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 224 participants in total. It began in 2026-06-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Children of both genders aged from 3 to 12 years. 2. Written informed consent obtained from the parents/legally authorized representatives 3. Written assent obtained from the subject from 7 years 4. Subject presenting with a susceptibility to respiratory tract infections according to the investigator 5. No respiratory tract infection within 15 days before the randomization visit 6. 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. 7. A cooperative attitude and ability to correct use of PMBL® tablet. Exclusion Criteria: 1. Subject treated with bacterial lysates within the previous 6 months prior to V1 or ongoing treatment. 2. Body temperature ≥ 37.5°C at the randomization visit. 3. Pregnant/Lactating female or with sexual activity without hormonal contraception, intrauterine device or barrier methods. 4. Primary or secondary immunodeficiency, cystic fibrosis, bronchiectasis, alpha-1 antitrypsin deficiency, malignancy, endocrinological diseases or other chronic respiratory diseases, except asthma and allergic rhinitis. 5. Known sensitivity to the components of study medication. 6. Any major surgery within the last 3 months prior to study enrolment or planned to occur within the duration of study. 7. Treatment with the following medications: 1. Injection or oral administration of steroids within 4 weeks prior to study enrolment. 2. Previous and/or concomitant immunosuppressants, immunostimulants, allergen-immunotherapy or gamma globulins within 6 months prior to study enrolment. 8. Inability to understand or comply with study procedures or with study treatment intake. 9. Subject participating in another interventional clinical study at the time of screening visit.
Contact & Investigator
Andrzej EMERYK, MD, PhD
PRINCIPAL INVESTIGATOR
University Children Hospital, Lublin, Poland
Frequently Asked Questions
Who can join the NCT07578012 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 12 Years, studying Respiratory Tract Infections (RTI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07578012 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07578012 currently recruiting?
Yes, NCT07578012 is actively recruiting participants. Contact the research team at bgout@pharmndev.ch for enrollment information.
Where is the NCT07578012 trial being conducted?
This trial is being conducted at Bialystok, Poland, Bydgoszcz, Poland, Bydgoszcz, Poland, Krakow, Poland and 6 additional locations.
Who is sponsoring the NCT07578012 clinical trial?
NCT07578012 is sponsored by Lallemand Pharma AG. The principal investigator is Andrzej EMERYK, MD, PhD at University Children Hospital, Lublin, Poland. The trial plans to enroll 224 participants.