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OpenTrials
Completed

NCT Number: NCT01988558

A Phase I/II to Assess Safety, Tolerability and Efficacy of DL-lactic Acid Syrup 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.

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Key information

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clalit Health Services, Pediatric Community Ambulatory Clinic, Petah Tikva, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DL - Lactic Acid

Drug

Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored)

Raspberry flavored syrup

Dietary Supplement

Placebo group to receive Raspberry flavored Syrup

Primary outcomes

  1. Safety evaluation - Number of participants with adverse events

    Time frame: At 90 days post treatment

Secondary outcomes

  1. Tonsil Size

    Time frame: Chnge from baseline at 6 months post treatment

  2. Number of Tonsillitis episodes

    Time frame: Chnge in medical history number of recurrent Tonsillitis episodes within 6 months post treatment

Other outcomes

  1. QOL Questionnaire

    Time frame: Chnge from baseline at 90 days post treatment

Sponsors and collaborators

Lead sponsor

Yali Pharmaceuticals

Industry

Registry information

Official study title

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.

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2013
Registry last updated
Oct 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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