Status:
UNKNOWN
Effect of OM-85 on Respiratory Tract Infections and Adenoid Tissue in Children With Adenoid Hypertrophy
Lead Sponsor:
Dr. Sami Ulus Children's Hospital
Conditions:
Adenoid Hypertrophy
Adenoid Hyperplasia
Eligibility:
All Genders
2-6 years
Phase:
PHASE4
Brief 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 consequ...
Detailed Description
OM-85 significantly reduces RTIs in children. This effect was proved by many clinical studies and meta-analyses. A Cochrane meta-analysis first published in 2006 and updated recently (Del-Rio-Navarro ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2019
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03243565
Start Date
November 1 2017
End Date
May 1 2019
Last Update
October 5 2017
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