RecruitingNot ApplicableNCT07235826

Evaluation of the Efficacy of Streptococcus Salivarius Evol12® in the Reduction of Recurrent Adenotonsillitis in Children

Evaluation of the Efficacy of Streptococcus Salivarius Evol12® in the Reduction of Recurrent Adenotonsillitis in Children: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Cross-over Clinical Trial

Sponsor

Liaquat University of Medical & Health Sciences

Enrollment

200 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Recurrent tonsillitis

Summary

This prospective, multicenter, randomized, double-blind, placebo-controlled, cross-over clinical trial will evaluate the efficacy and safety of Streptococcus salivarius Evol12® (Bactoblis® Evol) in reducing the recurrence and duration of acute febrile adenotonsillitis in children aged 3 to 11 years. Participants will receive either the probiotic or a matching placebo for 3 months, followed by a 7-day wash-out and a second 3-month treatment period with the alternative product. The study will assess changes in the incidence and duration of adenotonsillar episodes, antibiotic use, school absences, and sleep quality.

Eligibility

Min Age: 3 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Bactoblis® Evol (Streptococcus salivarius Evol12®) and Placebo for people with recurrent tonsillitis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 3 Years to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTBactoblis® Evol (Streptococcus salivarius Evol12®)

Bactoblis® Evol is an orodispersible tablet containing the probiotic strain Streptococcus salivarius Evol12® (LMG P-33696), used to support the balance of the oral microbiota. Each tablet is taken once daily in the evening, allowing it to dissolve slowly in the mouth without chewing, eating, or drinking afterward. Treatment is administered for 3 consecutive months during each treatment period. The product is manufactured by PharmExtracta S.p.A., Pontenure, Italy.

OTHERPlacebo

Matching placebo orodispersible tablet identical in appearance, flavor, and packaging to Bactoblis® Evol but without the active probiotic strain. Administered once daily in the evening for 3 months during the assigned treatment period.

Locations(1)

Università di Urbino Carlo Bo

Urbino, PU (Pesaro E Urbino), Italy

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NCT07235826