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
Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 11
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
Università di Urbino Carlo Bo
RECRUITING
Urbino
Contact Information
Primary
Davide Sisti, PhD
davide.sisti@uniurb.it
+39-0722-303301
Time Frame
Start Date:2025-09-01
Estimated Completion Date:2026-06-30
Participants
Target number of participants:200
Treatments
Experimental: Bactoblis® Evol
Participants randomized to Sequence A will receive Streptococcus salivarius Evol12® (Bactoblis® Evol) for 3 months, followed by a 7-day wash-out, then matching placebo for 3 months. Bactoblis® Evol is taken as 1 orodispersible tablet nightly, allowed to dissolve slowly in the mouth.
Placebo_comparator: Placebo
Participants randomized to Sequence B will receive matching placebo for 3 months, followed by a 7-day wash-out, then Streptococcus salivarius Evol12® (Bactoblis® Evol) for 3 months. The placebo tablets are identical in appearance, taste, and packaging to the active product.