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

Phase 1

Completed

• Conditions: Recurrent Tonsillitis in Children
• Interventions: Dietary Supplement: Raspberry flavored syrup; Drug: DL - Lactic Acid

• Registration Number: NCT01988558
• Lead Sponsor: Yali Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-03
• Study First Submitted QC: 2013-11-11
• Study First Posted: 2013-11-20
• Study Start: 2013-12
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Raspberry flavored syrup	-
Treated Group	DL - Lactic Acid	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.

Primary Outcome Measures

Name	Time	Method
Safety evaluation - Number of participants with adverse events	At 90 days post treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Assaf Harofeh Medical Center; 🇮🇱 Tzrifin, Israel

Clalit Health Services, Pediatric Community Ambulatory Ganei Hadar clinic; 🇮🇱 Petach Tikva, Israel

Clalit Health Services, Pediatric Community Ambulatory Clinic; 🇮🇱 Petach Tikva, Israel