- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03449836
Effects of the Direct Interaction Between Streptococcus Salivarius 24SMBc and Streptococcus Oralis 89a and the Respiratory Epithelium in Children
Effects of the Direct Interaction Between Streptococcus Salivarius 24SMBc and Streptococcus Oralis 89a With the Respiratory Epithelium in Children Affected by Allergic Rhinoconjunctivitis
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children aged 6-12 months with allergic rhinoconjunctivitis
Exclusion Criteria:
- concomitant presence of chronic pathologies,
- malformations of the respiratory tract and facial cranium,
- tumors,
- neurological diseases,
- metabolic pathologies,
- cystic fibrosis,
- immunodeficiencies,
- history of epistaxis,
- alteration of coagulation factors,
- history of apnea,
- ciliary dyskinesia,
- treatment with topical drugs nasal steroids and / or oral anti-histaminics or antibiotic treatment in the 3 months prior to enrollment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Streptococcus salivarius 24SMBc + Strept.oralis 89a
spray with Streptococcus salivarius 24SMBc + Strept.
oralis 89a
|
nasal spray based on Streptococcus salivarius 24SMBc + Strept.
oralis 89a
|
Active Comparator: fluticasone + mometasone
spray with fluticasone and mometasone
|
nasal spray based on fluticasone + mometasone
|
Placebo Comparator: placebo
spray with isotonic solution
|
nasal spray based on isotonic solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total 5 Symptom Score (T5SS) from 0 to 15
Time Frame: after 20 days of treatment
|
Symptoms evaluation was made by the Total 5 Symptoms Score (T5SS), which includes the symptoms of nasal discharge (rhinorrhea), nasal congestion, itchy nose, sneezing, and itchy eyes.
All symptoms were graded from 0 (absent) to 3 (very troublesome),with total scores ranging from 0-15.
|
after 20 days of treatment
|
Pittsburgh Sleep Quality Index (PSQI) score
Time Frame: after 20 days of treatment
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the 7 component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality. |
after 20 days of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of nasal microbiota composition
Time Frame: after 20 days of treatment
|
Evaluation of nasal microbiota composition with a nasal brushing and determination of phyla, class, order, family, genus
|
after 20 days of treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 274/17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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