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

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.

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

Study Overview

• Status: Completed
• Conditions: Recurrent Tonsillitis in Children
• Intervention / Treatment: Drug: DL - Lactic Acid; Dietary supplement: Raspberry flavored syrup

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel
    • Clalit Health Services, Pediatric Community Ambulatory Clinic
  • Petach Tikva, Israel
    • Clalit Health Services, Pediatric Community Ambulatory Ganei Hadar clinic
  • Tzrifin, Israel
    • Assaf Harofeh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group	Dietary supplement: Raspberry flavored syrup; Placebo group to receive Raspberry flavored Syrup
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.	Drug: DL - Lactic Acid; Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
QOL Questionnaire	Chnge from baseline at 90 days post treatment

Collaborators and Investigators

• Sponsor: Yali Pharmaceuticals
• Investigators: Principal Investigator: Mati Berkovitz, Prof., MOH

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: November 3, 2013
• First Submitted That Met QC Criteria: November 11, 2013
• First Posted (Estimate): November 20, 2013

Study Record Updates

• Last Update Posted (Estimate): October 7, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Recurrent Tonsillitis; Streptococcus A
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Recurrence; Tonsillitis
• Other Study ID Numbers: LA-001-IL