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
Liaquat University of Medical & Health Sciences
200 participants
Sep 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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.
Exclusion Criteria5
- Total obstruction of the nasal cavities.
- Uncontrolled gastroesophageal reflux disease.
- Unilateral tonsillar enlargement.
- Previous tonsil reduction surgery.
- Lack of parental or legal guardian consent to participate in the study.
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Interventions
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.
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)
View Full Details on ClinicalTrials.gov
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NCT07235826