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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01988558
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : October 7, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Recurrent Tonsillitis in Children Drug: DL - Lactic Acid Dietary Supplement: Raspberry flavored syrup Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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.
Study Start Date : December 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
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)

Placebo Comparator: Placebo Group Dietary Supplement: Raspberry flavored syrup
Placebo group to receive Raspberry flavored Syrup

Primary Outcome Measures :
  1. Safety evaluation - Number of participants with adverse events [ Time Frame: At 90 days post treatment ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. QOL Questionnaire [ Time Frame: Chnge from baseline at 90 days post treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01988558

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Clalit Health Services, Pediatric Community Ambulatory Clinic
Petach Tikva, Israel
Clalit Health Services, Pediatric Community Ambulatory Ganei Hadar clinic
Petach Tikva, Israel
Assaf Harofeh Medical Center
Tzrifin, Israel
Sponsors and Collaborators
Yali Pharmaceuticals
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Principal Investigator: Mati Berkovitz, Prof. MOH

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Responsible Party: Yali Pharmaceuticals Identifier: NCT01988558     History of Changes
Other Study ID Numbers: LA-001-IL
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016
Keywords provided by Yali Pharmaceuticals:
Recurrent Tonsillitis
Streptococcus A
Additional relevant MeSH terms:
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Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases