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

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Tract Infections; Adenoid Hypertrophy; Adenoid Hyperplasia; Preschool Children
• Intervention / Treatment: Biological: OM-85; Biological: Placebo

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 2012) showed that immunostimulants (IS) could reduce acute RTIs (ARTIs) by almost 39% when compared to placebo. Among the different IS, OM-85 showed the most robust evidence with 4 trials of "A quality" according to the Cochrane grading criteria. Pooling six OM-85 studies, the Cochrane review reported a mean number of ARTIs reduction by -1.20 [95% Confidence Interval (CI): -1.75, -0.66 ] and a percentage difference in ARTIs by -35.9% [95% CI: -49.46, -22.35 ] compared to placebo.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Serap Ozmen, MD; Phone Number: +903123056250; Email: serapozmen@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Biological: 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.; Other Names: Vaxoral
Placebo Comparator: 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.	Biological: Placebo; Pregelatinized starch (Starch 1500)+Mannitol+Magnesium stearate+Anhydrous propyl gallate+Sodium glutamate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in duration of RTIs	duration of RTIs (day)	within 12 months
Reduction of antibiotic use	number of antibiotic use	within 12 months
Reduction of missed school days	missed school days (day)	within 12 months
Reduction of surgery need	Whether or not surgery (adenoidectomy)	within 12 months
Adenoid and tonsil survey	before and after the study	within 12 months
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

Collaborators and Investigators

• Sponsor: Dr. Sami Ulus Children's Hospital
• Investigators: Study Chair: Serap Ozmen, Health of Science University, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, TURKEY

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: children; adenotonsillectomy; adenoid hypertrophy; respiratory tract infection; Adenoid Hyperplasia; OM-85
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Pathological Conditions, Anatomical; Infections; Communicable Diseases; Hyperplasia; Hypertrophy; Respiratory Tract Infections
• Other Study ID Numbers: 17-AKD-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No