Effect of OM-85 on Respiratory Tract Infections and Adenoid Tissue in Children With Adenoid Hypertrophy
NCT ID: NCT03243565
Last Updated: 2017-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
68 participants
INTERVENTIONAL
2017-11-01
2019-05-01
Brief Summary
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Detailed Description
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Adenoid hypertrophy (AH) is one of the most important respiratory disease in preschool children. In normal conditions adenoid tissue enlarges up to 5 years and become smaller afterwards. But in some children who have recurrent upper respiratory tract infections (URTI)s, it keeps growing and this can be associated with complications. AH may cause recurrent respiratory infections and each infection contribute to enlargement of adenoid tissue thus promoting a vicious cycle. Additionally enlarged adenoids are known to be reservoir for microbes and cause of recurrent or long lasting RTIs.
AH is associated with chronic cough, recurrent and chronic sinusitis, recurrent tonsillitis, recurrent otitis media with effusion, recurrent other respiratory problems such as, nasal obstruction and sleep disturbances, sleep apneas. Eventually, AH causes loss of appetite and growth delay; it is often associated with misusing or over use of antibiotics and often eventually requires surgery. It decreases quality of life both in children and parents and it represents a burden not only for families but also for health care system and society due to increased health cost4.
In one study which investigated the structural and immunological aspects of tonsils and adenoids of 105 children (54 males and 51 females, aged between 4 and 18 years) who were affected by chronic inflammatory hypertrophy of palatine tonsils and adenoids which had not responded to previous medical treatments and who underwent adenotonsillectomy because of recurrent inflammatory episodes with fever, it was demonstrated that deficit in the activa-tion of the immune system could be represented by the small quan-tity of messenger ribonucleic acid (mRNA)s for interleukin-2 (IL-2) and interleukin-4 (IL-4) detected in our population, suggesting a defective activation of Th1 and Th2 lymphocytes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
A second cure of treatment will be given 6 months after inclusion. Patients will be recruited from 01 August 2017 to 01 February 2018. The trial will begin in August 2017 and will be completed in February 2019.
By this way every patient will be studied over all seasons (1 year study) .
PREVENTION
QUADRUPLE
Study Groups
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OM-85
OM-85 by mouth (3.5 mg once per day, first 10 days, consecutive 3 months; 10-10-10 days, standard treatment regimen) A second cure of treatment will be given 6 months after inclusion.
OM-85
OM-85 is an oral bacterial lysate of 21 different strains of 8 species and sub-species of the most common respiratory tract pathogens.
Placebo
Placebo by mouth (Pregelatinized starch (Starch 1500)+Mannitol+Magnesium stearate+Anhydrous propyl gallate+Sodium glutamate) the same posology (3.5 mg once per day, first 10 days for consecutive 3 months) A second cure of treatment will be given 6 months after inclusion.
Placebo
Pregelatinized starch (Starch 1500)+Mannitol+Magnesium stearate+Anhydrous propyl gallate+Sodium glutamate
Interventions
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OM-85
OM-85 is an oral bacterial lysate of 21 different strains of 8 species and sub-species of the most common respiratory tract pathogens.
Placebo
Pregelatinized starch (Starch 1500)+Mannitol+Magnesium stearate+Anhydrous propyl gallate+Sodium glutamate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Years
6 Years
ALL
No
Sponsors
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Dr. Sami Ulus Children's Hospital
OTHER
Responsible Party
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Serap Ozmen
MD, Pediatric Allergist and Assoc. Prof of Pediatrics
Principal Investigators
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Serap Ozmen
Role: STUDY_CHAIR
Health of Science University, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, TURKEY
Central Contacts
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Provided Documents
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Document Type: Statistical Analysis Plan: SAP OM85adenoid
Document Type: Informed Consent Form: ICF OM85adenoid
Document Type: Study Protocol: SP OM85adenoid
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: SUM OM85adenoid
Other Identifiers
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17-AKD-2
Identifier Type: -
Identifier Source: org_study_id