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

NCT03243565 | Unknown Phase 4 DMC

• 1 other identifier: 17-AKD-2
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Adenoid Hypertrophy; Adenoid Hyperplasia; Respiratory Tract Infections; Preschool Children

Keywords

adenoid hypertrophy; Adenoid Hyperplasia; children; respiratory tract infection; adenotonsillectomy; OM-85

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Reduction in duration of RTIs

  within 12 months

• Reduction of antibiotic use

  within 12 months

• Reduction of missed school days

  within 12 months

• Reduction of surgery need

  within 12 months

• Adenoid and tonsil survey

  within 12 months

Study Arms (2)

OM-85

ACTIVE COMPARATOR

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.

Biological: OM-85

Placebo

PLACEBO COMPARATOR

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.

Biological: Placebo

Interventions

OM-85 BIOLOGICAL

OM-85 is an oral bacterial lysate of 21 different strains of 8 species and sub-species of the most common respiratory tract pathogens.

Also known as: Vaxoral

OM-85

Placebo BIOLOGICAL

Pregelatinized starch (Starch 1500)+Mannitol+Magnesium stearate+Anhydrous propyl gallate+Sodium glutamate

Placebo

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children (age: 2-6 years)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Sami Ulus Children's Hospital: lead

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Serap Ozmen

  Health of Science University, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, TURKEY

  STUDY CHAIR

Central Study Contacts

Serap Ozmen, MD

CONTACT

+903123056250; serapozmen@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done by throwing the coin. Family of patients and doctor (Coordinator / Responsible Investigator Serap Ozmen and Associate Investigator Soner Sahin) will be blind; Researcher Ilknur Bostanci and assistant researcher Gulay Senel will appoint drugs and placebo.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Pediatric Allergist and Assoc. Prof of Pediatrics

Model Details: A randomised, double-blind, placebo-controlled, parallel group, phase IV study. First group will receive OM-85 (first 10 day consecutive 3 months; standard treatment regimen) Second group will receive matching placebo at the same posology (first 10 day consecutive 3 months). 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) .

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 9, 2017
• Study Start: November 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 5, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share