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

Overview

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

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 2016

Interventions

  • Drug: DL – Lactic Acid
    • Treated group to receive DL – Lactic Acid Syrup (Raspberry flavored)
  • Dietary Supplement: Raspberry flavored syrup
    • Placebo group to receive Raspberry flavored Syrup

Arms, Groups and Cohorts

  • Experimental: Treated Group
    • 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.
  • Placebo Comparator: Placebo Group

Clinical Trial Outcome Measures

Primary Measures

  • Safety evaluation – Number of participants with adverse events
    • Time Frame: At 90 days post treatment

Secondary Measures

  • Tonsil Size
    • Time Frame: Chnge from baseline at 6 months post treatment
  • Number of Tonsillitis episodes
    • Time Frame: Chnge in medical history number of recurrent Tonsillitis episodes within 6 months post treatment

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yali Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mati Berkovitz, Prof., Principal Investigator, MOH

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