Daily Streptococcus salivarius Evol12 to reduce recurrent tonsillitis 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
This study will test whether a daily oral probiotic tablet (Streptococcus salivarius Evol12®) can reduce how often and how long feverish tonsillitis episodes occur in children aged 3–11.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 3 Years to 11 Years |
| Sex | All |
| Sponsor | Liaquat University of Medical & Health Sciences Academic / other |
| Locations | 1 site (Urbino, PU (Pesaro E Urbino)) |
| Trial ID | NCT07235826 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, randomized, double-blind, placebo-controlled crossover trial enrolling 200 children aged 3–11 with at least three documented febrile adenotonsillitis episodes in the prior 12 months. Participants receive one orodispersible S. salivarius Evol12® tablet nightly for 3 months followed by a 7-day washout and 3 months of placebo, or vice versa. The primary outcome is change in incidence and duration of acute febrile adenotonsillitis measured by the WURSS‑K, with secondary outcomes including antibiotic use, school absences, sleep quality (OSA‑18), and safety monitoring. S. salivarius Evol12® is a commensal-derived probiotic strain developed to restore oral microbial balance and has a favorable microbiological and resistance profile.
Who should consider this trial
Good fit: Children aged 3–11 with a history of three or more documented episodes of acute febrile adenotonsillitis in the previous 12 months whose parent or guardian can provide informed consent.
Not a fit: Children with total nasal obstruction, uncontrolled gastroesophageal reflux, unilateral tonsillar enlargement, previous tonsil surgery, or without recurrent febrile adenotonsillitis are unlikely to benefit from this probiotic approach.
Why it matters
Potential benefit: If successful, the probiotic could reduce the frequency and length of feverish tonsillitis episodes, lower antibiotic use and missed school days, and improve sleep for affected children.
How similar studies have performed: Small studies of oral probiotics, including S. salivarius strains, have shown promise for reducing pharyngitis and related infections, but large randomized pediatric crossover data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Urbino, PU (Pesaro E Urbino)
- Università di Urbino Carlo Bo — Urbino, PU (Pesaro E Urbino), Italy (Recruiting)
Study contacts
- Study coordinator: Davide Sisti, PhD
- Email: davide.sisti@uniurb.it
- Phone: +39-0722-303301
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.