Respiratory Tract Infections Clinical Trial
Official title:
Effect of Vaxoral® (OM-85) on Frequency of Respiratory Tract Infections and Size of Adenoid Tissue in Preschool Children With Adenoid Hypertrophy
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.
Status | Not yet recruiting |
Enrollment | 68 |
Est. completion date | May 1, 2019 |
Est. primary completion date | May 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 6 Years |
Eligibility |
Inclusion Criteria: - Children (age: 2-6 years) - Who experienced recurrent RTIs (at least 3 episodes in 6 months before the inclusion) - Who have symptoms of AH (snoring; mouth breathing awake; mouth breathing asleep; nasal congestion; hyponasal voice; chronic nasal discharge; daytime drowsiness, or hyperactivity; restless sleep; sleep apnoea <15 sec; night cough; and poor oral intake/weight loss) based on the symptoms score questionnaire Exclusion Criteria: - Atopy - Gastroesophageal reflux - Immune deficiency - Asthma or allergic rhinitis - Premature delivery - Anatomic alterations of the respiratory tract; chronic respiratory diseases (tuberculosis and cystic fibrosis); autoimmune disease; liver - Kidney failure; malnutrition; cancer - Treatment with inhaled or systemic corticosteroids within the previous month - Treatment with immunosuppressants, immunostimulants, gamma globulins, or anticonvulsive drugs within the previous 6 months. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dr. Sami Ulus Children's Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of number of respiratory tract infections (RTIs) | number of respiratory tract infections (RTIs) such as adenoiditis, sinusitis, tonsillitis, otitis, bronchitis | within 12 months | |
Secondary | Reduction in duration of RTIs | duration of RTIs (day) | within 12 months | |
Secondary | Reduction of antibiotic use | number of antibiotic use | within 12 months | |
Secondary | Reduction of missed school days | missed school days (day) | within 12 months | |
Secondary | Reduction of surgery need | Whether or not surgery (adenoidectomy) | within 12 months | |
Secondary | Adenoid and tonsil survey | before and after the study | within 12 months | |
Secondary | Size of adenoid tissue over the 12 months according to radiographic and flexible nasopharyngoscopic evaluation | The data will be recorded as a perceived percent obstruction of the choana by the adenoid pad, as seen through the endoscope; Lateral neck radiographs will taken and interpreted by the method of Cohen and Konak by a blinded radiologist (Cohen D, Konak S. The evaluation of radiographs of the nasopharynx. Clin Otolaryngol 1985; 10: 73-8.) | 1 year |
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