A Phase I/II to Assess Safety, Tolerability and Efficacy of DL-lactic Acid Syrup in Children With Recurrent Tonsillitis

Study Overview
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Brief Summary
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The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.

Official Title
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A Phase I/II, Randomized, Double Blind, Placebo-controlled Study to Assess the Safety, Tolerability and Efficacy of DL-lactic Acid Syrup (Tonsitin) in Children With Recurrent Tonsillitis.

Conditions
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Recurrent Tonsillitis in Children

Intervention / Treatment
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* Drug: DL - Lactic Acid
* Dietary Supplement: Raspberry flavored syrup


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated Group<br>Children diagnosed as suffering from recurrent Tonsillitis (at least 4 episodes per year) to receive DL-Lactic acid syrup twice a day for a month. | Drug: DL - Lactic Acid<br>* Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored)<br>|
| Placebo Comparator: Placebo Group<br> | Dietary Supplement: Raspberry flavored syrup<br>* Placebo group to receive Raspberry flavored Syrup<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation - Number of participants with adverse events |  | At 90 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Tonsillitis, Streptococcus A