Adenoid HypertrophyPhase 4NCT03243565
Effect of OM-85 on Respiratory Tract Infections and Adenoid Tissue in Children With Adenoid Hypertrophy
A Phase 4 study testing OM-85 in people with Adenoid Hypertrophy and Adenoid Hyperplasia, run by Dr. Sami Ulus Children's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Adenoid Hypertrophy, Adenoid Hyperplasia, Respiratory Tract Infections
- What is being tested?
- OM-85
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 1 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Adenoid Hypertrophy, Adenoid Hyperplasia, Respiratory Tract Infections, Preschool Children
- Being tested
- OM-85, Placebo
- Keywords
- adenoid hypertrophy, Adenoid Hyperplasia, children, respiratory tract infection, adenotonsillectomy, OM-85
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OM-85Biological
Also called Vaxoral
OM-85 is an oral bacterial lysate of 21 different strains of 8 species and sub-species of the most common respiratory tract pathogens.
PlaceboBiological
Pregelatinized starch (Starch 1500)+Mannitol+Magnesium stearate+Anhydrous propyl gallate+Sodium glutamate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of number of respiratory tract infections (RTIs)
number of respiratory tract infections (RTIs) such as adenoiditis, sinusitis, tonsillitis, otitis, bronchitis
Measured: within 12 months
Secondary outcomes (6)
Reduction in duration of RTIs
duration of RTIs (day)
Measured: within 12 months
Reduction of antibiotic use
number of antibiotic use
Measured: within 12 months
Reduction of missed school days
missed school days (day)
Measured: within 12 months
Reduction of surgery need
Whether or not surgery (adenoidectomy)
Measured: within 12 months
Adenoid and tonsil survey
before and after the study
Measured: 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.)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Sami Ulus Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Ozmen, Dr. Sami Ulus Children's Hospital
- Investigators
- Serap Ozmen, Study chair, Health of Science University, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243565
- Sponsor's protocol ID
- 17-AKD-2
- Status last verified
- Oct 2017
- First submitted
- 26 Jul 2017
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vaxoral® (OM-85) on Frequency of Respiratory Tract Infections and Size of Adenoid Tissue in Preschool Children With Adenoid Hypertrophy
- ClinicalTrials.gov ID
- NCT03243565
- Acronym / sponsor ID
- 17-AKD-2
- Conditions
- Adenoid Hypertrophy, Adenoid Hyperplasia, Respiratory Tract Infections, Preschool Children
- Keywords
- adenoid hypertrophy, Adenoid Hyperplasia, children, respiratory tract infection, adenotonsillectomy, OM-85
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Dr. Sami Ulus Children's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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) .
| Arm | Type | Receives |
|---|---|---|
| OM-85 | Active comparator | Biological: OM-85OM-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. |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Atopy
- Gastroesophageal reflux
- Immune deficiency
- Asthma or allergic rhinitis
- Premature delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OM-85Also: VaxoralOM-85 is an oral bacterial lysate of 21 different strains of 8 species and sub-species of the most common respiratory tract pathogens. | Biological | OM-85 |
| PlaceboPregelatinized starch (Starch 1500)+Mannitol+Magnesium stearate+Anhydrous propyl gallate+Sodium glutamate | Biological | Placebo |
Primary outcome
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
6 secondary outcomes
Reduction in duration of RTIs
Time frame: within 12 months
Reduction of antibiotic use
Time frame: within 12 months
Reduction of missed school days
Time frame: within 12 months
Reduction of surgery need
Time frame: within 12 months
Adenoid and tonsil survey
Time frame: within 12 months
Size of adenoid tissue over the 12 months according to radiographic and flexible nasopharyngoscopic evaluation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Adenoid Hypertrophy
RecruitingObservational study
Serum and Salivary Leptin Levels in Children With Adenoid/Adenotonsillar Hypertrophy
Adenoid Hypertrophy, Adenotonsillar Hypertrophy
Not yet recruiting
Full-wrap Versus Conventional Suspension for Reducing Soft Palate Injury Rate in Transoral Surgery
Adenoid Hypertrophy, Tonsillar Hypertrophy
Not yet recruitingObservational study
Evaluation of the Effects of Adenoidectomy and Adenotonsillectomy on Voice in Children
Adenoid Hypertrophy, Tonsillar Hypertrophy
RecruitingObservational study
Evaluation of the Effect of Adenoid Hypertrophy on the Masseter Muscle in Children: A Comparative Ultrasonographic Study
Adenoid Hypertrophy, Masseter Muscle
Active, not recruitingObservational study
Metabolomic Profiling of Racial Disparity
Adenoid Hypertrophy, Tonsillar Hypertrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serap Ozmen study chair
Health of Science University, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, TURKEY
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OM-85 in people with Adenoid Hypertrophy and Adenoid Hyperplasia, run by Dr. Sami Ulus Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serap Ozmen, MD (+903123056250, serapozmen@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of number of respiratory tract infections (RTIs) (time frame: within 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.