OM-85 in the prevention of asthma in high-risk childre

Phase 3

Completed

• Conditions: Asthma; Respiratory - Asthma; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12612000518864
• Lead Sponsor: Child Health Research Centre, University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Children of either sex, aged 3-9 months old whose biological mother, father, or sibling has a history of asthma and/or atopy (defined as SPT reactivity to one or more allergen, food allergy, atopic dermatitis or allergic rhinitis) 2. Participants who, in the opinion of the investigator, are able to comply with the protocol for its duration 3. Written informed consent signed and dated by parent/legal guardian according to local regulations

Exclusion Criteria

1.Children born less than 36 weeks gestation

2.Children who have been diagnosed with asthma

3.Children who have chronic pulmonary disease or other chronic disease (other than atopic dermatitis, food allergy, or chronic rhinitis) requiring therapy

4.Participation in another randomized controlled trial within the 3 months preceding inclusion in this study

5.Children who has previously received OM-85 or other immunostimulant or immunosuppressive drugs including cyclosporine

Study & Design

• Study Type: Interventional
• Study Design: Not specified