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OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness

NCT05677763 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2026-03-24

No results posted yet for this study

Summary

This study will assess the efficacy and safety of OM-85 compared to placebo in reducing the number of respiratory tract infections (RTIs) in children aged between 6 months and 5 years.

Conditions

  • Respiratory Tract Infections
  • Wheezing Lower Respiratory Illness

Interventions

DRUG

OM-85

Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month)

DRUG

Placebo

Subjects will be administered Placebo once daily. (10 days per month)

Sponsors & Collaborators

  • OM Pharma SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2026-03-10
Completion
2026-09-16

Countries

  • Germany
  • Hungary
  • Italy
  • Poland
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

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 NCT05677763 on ClinicalTrials.gov