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Prevention With Ismigen of RTIs in Kids

NCT07578012 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Respiratory Tract Infections (RTI)
  • Healthy Children

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

Sponsors & Collaborators

  • Lallemand Pharma AG

    lead INDUSTRY

Principal Investigators

  • Andrzej EMERYK, MD, PhD · University Children Hospital, Lublin, Poland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-03-31
Completion
2027-04-30

Countries

  • Poland

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07578012 on ClinicalTrials.gov