Evaluation of the Efficacy of Streptococcus Salivarius Evol12® in the Reduction of Recurre
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 r
| Condition(s) | Recurrent Tonsillitis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * 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 Criteria: * 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. |
| Ages | 3 Years to 11 Years |
| Sex | All |
| Lead sponsor | Liaquat University of Medical & Health Sciences |
| Locations | Urbino, PU (Pesaro E Urbino), Italy |
| Start date | 2025-09-01 |
| NCT ID | NCT07235826 |
| Official listing | https://clinicaltrials.gov/study/NCT07235826 |