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.
Male and female children aged 3 to 11 years.
History of ≥3 documented episodes of acute adenotonsillitis within the previous 12 months, each characterized by fever ≥38°C.
Signed and accepted informed consent from a parent or legal guardian.
Total obstruction of the nasal cavities.
Uncontrolled gastroesophageal reflux disease.
Unilateral tonsillar enlargement.
Previous tonsil reduction surgery.
Liaquat University of Medical & Health Sciences
Lead sponsor
University of Urbino "Carlo Bo"
Collaborator