Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluation of the Efficacy of Streptococcus Salivarius Evol12® in the Reduction of Recurrent Adenotonsillitis in Children
Sponsor: Liaquat University of Medical & Health Sciences
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.
Official title: 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
Key Details
Gender
All
Age Range
3 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-09-01
Completion Date
2026-06-30
Last Updated
2025-11-19
Healthy Volunteers
No
Conditions
Interventions
Bactoblis® 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.
Placebo
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