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

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.

NCT Number	NCT07235826
Lead Sponsor	Liaquat University of Medical & Health Sciences Collaborators: University of Urbino "Carlo Bo"
Conditions	Recurrent Tonsillitis
Enrollment	216 participants
Start Date	2025-11-26
Primary Completion	2026-07-23 (estimated)
Study Completion	2026-07-23 (estimated)
Updated on ClinicalTrials.gov	2026-07-24