Prevention With Ismigen of RTIs in Kids

NCT07578012 | Not Yet Recruiting Phase 4

• 2 other identifiers: LPI-25012025-524212-11-00
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 8

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.

Conditions

Respiratory Tract Infections (RTI); Healthy Children

Keywords

Respiratory Tract Infections (RTI); Bacterial Lysates; PMBL® sublingual tablets; Recurrent Respiratory Tract Infections; Ismigen; Incidence

Outcome Measures

Primary Outcomes (1)

• The total number of RTIs experienced by each subject throughout the 7-month study period (3-month treatment + 4-month follow-up).

  Rate of Respiratory Tract Infections (RTIs): the number of RTIs experienced by a subject throughout the study (3 month-treatment period and 4 month-follow-up) will be assessed.

  Throughout the 7-month study period (3-month treatment + 4-month follow-up).

Secondary Outcomes (7)

• Mean duration in days per RTI during the overall study period.

  Throughout the 7-month study period (3-month treatment + 4-month follow-up).

• Number of days with respiratory tract infections during the overall study period

  Throughout the 7-month study period (3-month treatment + 4-month follow-up).

• Number of days of antibiotics use during the overall study period

  Throughout the 7-month study period (3-month treatment + 4-month follow-up).

• Total number of workdays lost by parents due to their child's respiratory infections during the overall study period.

  Throughout the study (3 month-treatment period and 4 month-follow-up)

• Number of physician consultations due to RTI or related complications.

  Throughout the study (3 month-treatment period and 4 month-follow-up)

Study Arms (2)

PMBL® sublingual tablet

ACTIVE COMPARATOR

Ismigen® (Polyvalent Mechanical Bacterial Lysate; PMBL) is a sublingual tablet marketed by Lallemand Pharma Europe. Each tablet contains: * Lyophilised bacterial lysate 50 mg * Excipients q.s. 250mg The posology of Ismigen® for paediatric population (from 3 years of age) is one tablet per day before food, to be dissolved under the tongue. Use for ten consecutive days per month, over a period of 3 months.

Drug: Bacterial Lysates

Placebo

PLACEBO COMPARATOR

The comparator is a sublingual tablet, indistinguishable from the investigational product. Each tablet of placebo comparator has the same composition as the investigational medicinal product being tested (with the exception of the active substance, which is replaced by glycine (7 mg)). Posology, instructions for use, contraindications, precautions of use and labelling are identical to those for Ismigen®. The posology of Placebo is one tablet per day before food, to be dissolved under the tongue. Use for ten consecutive days per month, over a period of 3 months.

Drug: Placebo

Interventions

Bacterial Lysates DRUG

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

Also known as: PMBL® sublingual tablet, ISMIGEN®

PMBL® sublingual tablet

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Lallemand Pharma AG: lead

Study Sites (8)

Research Site

Bialystok, Poland

Location

Research Site

Bydgoszcz, Poland

Location

Research Site

Krakow, Poland

Location

Research Site

Krąków, Poland

Location

Research Site

Lublin, Poland

Location

Research Site

Oświęcim, Poland

Location

Research Site

Poznan, Poland

Location

Research Site

Tarnów, Poland

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Bacterial Lysates; Broncho-Vaxom

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Andrzej EMERYK, MD, PhD

  University Children Hospital, Lublin, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernard GOUT, PharmD, PhD

CONTACT

+33776583905; bgout@pharmndev.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized double-blind Placebo-controlled

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

PL (8)