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OM 85 in Paediatric Recurrent Respiratory Tract Infections with Wheezing Lower Respiratory Illness
EU CTIS ID: 2024-511581-37-00
What this study is testing
Primary efficacy objective is to assess the efficacy of short- and long-term treatment with OM 85 vs. placebo in reducing the number of RTIs in children aged between 6 months and 5 years with recurrent RTIs associated with wLRI during the 12-month Treatment period.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Children of either gender aged between 6 months and 5 years at Baseline/Randomisation (Visit 2), inclusive. As requested by the Central Ethics Committee, in Italy children can be enrolled if they are between 1 year and 5 years of age at baseline/Randomisation (Visit 2).
- For children ≥1 year of age, ≥4 RTIs (as reported by parents or LAR of subject), including ≥2 episodes of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 12 months prior to enrolment. OR For children <1 year of age, ≥2 RTIs (as reported by parents or LAR of subject), including ≥1 episode of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 6 months prior to enrolment.
- Parents or LAR of subject have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures.
You likely can't join if
- Anatomic alterations of the respiratory tract.
- Any known neoplasia or malignancy.
- Treatment with the following medications: a. Injection or oral steroids administration within 4 weeks prior to study enrolment. b. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to study enrolment.
- Previous use within last 6 months of enrolment or ongoing use of bacterial lysates.
- Any major surgery within the last 3 months prior to study enrolment.
- Known allergy or previous intolerance to investigational medicinal products (IMP).
See the full eligibility criteria
- Children of either gender aged between 6 months and 5 years at Baseline/Randomisation (Visit 2), inclusive. As requested by the Central Ethics Committee, in Italy children can be enrolled if they are between 1 year and 5 years of age at baseline/Randomisation (Visit 2).
- For children ≥1 year of age, ≥4 RTIs (as reported by parents or LAR of subject), including ≥2 episodes of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 12 months prior to enrolment. OR For children <1 year of age, ≥2 RTIs (as reported by parents or LAR of subject), including ≥1 episode of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 6 months prior to enrolment.
- Parents or LAR of subject have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures.
- Anatomic alterations of the respiratory tract.
- Any known neoplasia or malignancy.
- Treatment with the following medications: a. Injection or oral steroids administration within 4 weeks prior to study enrolment. b. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to study enrolment.
- Previous use within last 6 months of enrolment or ongoing use of bacterial lysates.
- Any major surgery within the last 3 months prior to study enrolment.
- Known allergy or previous intolerance to investigational medicinal products (IMP).
- Any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study.
- No other household members have previously been randomised in this clinical study.
- Subjects' families expected to relocate out of study area within 24 months of the initiation of the study.
- Currently enrolled in or has completed any other investigational device or drug study or receiving other investigational agent(s) within <30 days prior to screening.
- Parents or LAR who do not have access to internet connection.
- Other respiratory chronic diseases (e.g., tuberculosis, cystic fibrosis).
- Wheezing documented to be caused by gastroesophageal reflux.
- Any autoimmune disease.
- HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).
- Known severe congenital heart disease.
- Haematologic diseases.
- Liver or kidney failure.
- New-borns before 34 weeks of gestational age.
- Malnutrition as per World Health Organization (WHO) definition, meaning children having a weight lower than the 5th percentile and higher than the 85th percentile for their age range according to WHO weight for age charts from birth to 5 years. Children of 6 months of age at enrolment will be excluded from the study if they have a weight lower than 6 kg and 6.6 kg, for girls and boys respectively.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.