A Phase I/II to Assess Safety, Tolerability and Efficacy of DL-lactic Acid Syrup in Children With Recurrent Tonsillitis
Primary Purpose
Recurrent Tonsillitis in Children
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
DL - Lactic Acid
Raspberry flavored syrup
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Tonsillitis in Children focused on measuring Recurrent Tonsillitis, Streptococcus A
Eligibility Criteria
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.
Sites / Locations
- Clalit Health Services, Pediatric Community Ambulatory Clinic
- Clalit Health Services, Pediatric Community Ambulatory Ganei Hadar clinic
- Assaf Harofeh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treated Group
Placebo Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Safety evaluation - Number of participants with adverse events
Secondary Outcome Measures
Tonsil Size
Number of Tonsillitis episodes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01988558
Brief Title
A Phase I/II to Assess Safety, Tolerability and Efficacy of DL-lactic Acid Syrup in Children With Recurrent Tonsillitis
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yali Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Tonsillitis in Children
Keywords
Recurrent Tonsillitis, Streptococcus A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treated Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DL - Lactic Acid
Intervention Description
Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored)
Intervention Type
Dietary Supplement
Intervention Name(s)
Raspberry flavored syrup
Intervention Description
Placebo group to receive Raspberry flavored Syrup
Primary Outcome Measure Information:
Title
Safety evaluation - Number of participants with adverse events
Time Frame
At 90 days post treatment
Secondary Outcome Measure Information:
Title
Tonsil Size
Time Frame
Chnge from baseline at 6 months post treatment
Title
Number of Tonsillitis episodes
Time Frame
Chnge in medical history number of recurrent Tonsillitis episodes within 6 months post treatment
Other Pre-specified Outcome Measures:
Title
QOL Questionnaire
Time Frame
Chnge from baseline at 90 days post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mati Berkovitz, Prof.
Organizational Affiliation
MOH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clalit Health Services, Pediatric Community Ambulatory Clinic
City
Petach Tikva
Country
Israel
Facility Name
Clalit Health Services, Pediatric Community Ambulatory Ganei Hadar clinic
City
Petach Tikva
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Tzrifin
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Phase I/II to Assess Safety, Tolerability and Efficacy of DL-lactic Acid Syrup in Children With Recurrent Tonsillitis
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