ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03243565
Recruitment Status : Not yet recruiting
First Posted : August 9, 2017
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Serap Ozmen, Dr. Sami Ulus Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Adenoid Hypertrophy Adenoid Hyperplasia Respiratory Tract Infections Preschool Children Biological: OM-85 Biological: Placebo Phase 4

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  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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) .

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Effect of Vaxoral® (OM-85) on Frequency of Respiratory Tract Infections and Size of Adenoid Tissue in Preschool Children With Adenoid Hypertrophy
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids

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 Name: 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




Primary Outcome Measures :
  1. Reduction of number of respiratory tract infections (RTIs) [ Time Frame: within 12 months ]
    number of respiratory tract infections (RTIs) such as adenoiditis, sinusitis, tonsillitis, otitis, bronchitis


Secondary Outcome Measures :
  1. Reduction in duration of RTIs [ Time Frame: within 12 months ]
    duration of RTIs (day)

  2. Reduction of antibiotic use [ Time Frame: within 12 months ]
    number of antibiotic use

  3. Reduction of missed school days [ Time Frame: within 12 months ]
    missed school days (day)

  4. Reduction of surgery need [ Time Frame: within 12 months ]
    Whether or not surgery (adenoidectomy)

  5. Adenoid and tonsil survey [ Time Frame: within 12 months ]
    before and after the study

  6. Size of adenoid tissue over the 12 months according to radiographic and flexible nasopharyngoscopic evaluation [ Time Frame: 1 year ]
    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.)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243565


Contacts
Contact: Serap Ozmen, MD +903123056250 serapozmen@yahoo.com

Sponsors and Collaborators
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 Documents (Full-Text)

Documents provided by Serap Ozmen, Dr. Sami Ulus Children's Hospital:
Study Protocol: SP OM85adenoid  [PDF] March 23, 2017


Responsible Party: Serap Ozmen, MD, Pediatric Allergist and Assoc. Prof of Pediatrics, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT03243565     History of Changes
Other Study ID Numbers: 17-AKD-2
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Serap Ozmen, Dr. Sami Ulus Children's Hospital:
adenoid hypertrophy
Adenoid Hyperplasia
children
respiratory tract infection
adenotonsillectomy
OM-85

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hyperplasia
Respiratory Tract Infections
Hypertrophy
Pathologic Processes
Respiratory Tract Diseases
Pathological Conditions, Anatomical