Recurrent Tonsillitis in Children
Conditions
Keywords
Recurrent Tonsillitis, Streptococcus A
Brief summary
The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.
Interventions
DRUGDL - Lactic Acid
Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored)
DIETARY_SUPPLEMENTRaspberry flavored syrup
Placebo group to receive Raspberry flavored Syrup
Sponsors
Yali Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Children at the ages of 5-16. * Patient is suffering from recurrent documented sore throat with at least 4 tonsillitis episodes during the preceding year (at least one verified by culture or rapid antigen testing for Streptococcus A). * Patient with clinical presentation of irregular tonsils. * Tonsils size graded between 2.5-4. * Clinical diagnosis of bacterial known in recurrent pharyngeal-tonsillitis. * Patient is willing to participate in the study and adhere to the study protocol * Patient's guardian and/or Patient have signed informed consent.
Exclusion criteria
* Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes (Positive RSAT or microbial culture). * Subjects who are known as Streptococcus pyogenes carriers * Subject's requiring any other medication (topical or systemic) that may affect the course of the disease during the study period (e.g. antibiotics, sedating antihistamines), and/or did not completed 14 days from end of antibiotics treatment. * Subjects with known hypersensitivity to lactose. * Subject is suffering from peritonsillar abscess. * Subject suffers from an active peptic ulcer * Subjects who are suffering from any concomitant disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study results. * Subject is currently participating in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation - Number of participants with adverse events | At 90 days post treatment |
Secondary
| Measure | Time frame |
|---|---|
| Tonsil Size | Chnge from baseline at 6 months post treatment |
| Number of Tonsillitis episodes | Chnge in medical history number of recurrent Tonsillitis episodes within 6 months post treatment |
Other
| Measure | Time frame |
|---|---|
| QOL Questionnaire | Chnge from baseline at 90 days post treatment |
Countries
Israel
Outcome results
None listed