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

Yali Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Recurrent Tonsillitis in Children

Treatments: Dietary Supplement: Raspberry flavored syrup; Drug: DL - Lactic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01988558

LA-001-IL

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 2 patient groups, including a placebo group

Treated Group

Experimental group

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.

Treatment:

Drug: DL - Lactic Acid

Placebo Group

Placebo Comparator group

Treatment:

Dietary Supplement: Raspberry flavored syrup