drugset / Trial / NCT03243565

Effect of OM-85 on Respiratory Tract Infections and Adenoid Tissue in Children With Adenoid Hypertrophy

NCT03243565

Phase 4 Unknown 68 enrolled Dr. Sami Ulus Children's Hospital
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Clinical research question: Can OM-85 reduce the recurrence of respiratory tract infections (RTIs) in children with AH by stimulating the immunological response of the host and therefore, as a consequence reduce the size of adenoid tissue in children with adenoid hypertrophy? Can this prevent further complications such as surgery need? Half of participants will receive OM-85, while other half will receive a placebo.

Timeline

Start
2017-11-01
Primary completion
2019-05-01
Completion
2019-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Broncho-Vaxom Other / unclassified 3.5 mg Oral