An interventional study of Bactoblis® Evol (Streptococcus salivarius Evol12®) and Placebo in Recurrent Tonsillitis, sponsored by Liaquat University of Medical & Health Sciences. Completed at 1 site in Italy. Open to participants aged 3 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Liaquat University of Medical & Health Sciences · Not applicable, Interventional, and Prevention
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.
Recurrent adenotonsillitis in children is a frequent and burdensome condition, often leading to repeated antibiotic use, missed school days, and sleep disturbances. Streptococcus salivarius is a naturally occurring commensal bacterium of the oral microbiota with demonstrated ability to inhibit Streptococcus pyogenes and other pathogens responsible for pharyngotonsillitis. Streptococcus salivarius Evol12® is a novel probiotic strain with a safe microbiological profile and no antibiotic resistance, developed to restore oral microbial balance and reduce recurrent infections of the upper airways.
This non-profit, prospective, multicenter, randomized, double-blind, placebo-controlled, cross-over study will enroll 216 pediatric participants aged 3 to 11 years with a history of at least three documented episodes of acute febrile adenotonsillitis in the preceding 12 months. Participants will be randomized to receive either one orodispersible tablet of S. salivarius Evol12® (Bactoblis® Evol, PharmExtracta S.p.A., Italy) daily in the evening for 3 months followed by placebo for 3 months, or vice versa, with a 7-day wash-out period between treatments.
The primary objective is to evaluate the efficacy of S. salivarius Evol12® in reducing the duration and recurrence of acute febrile adenotonsillitis, as measured by the Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K).
Secondary objectives include assessment of sleep disorders (OSA-18 questionnaire), number and duration of feverish episodes, school days missed, antibiotic use, and symptom severity (e.g., sore throat, tonsil exudate, difficulty swallowing, otitis, cough, and fatigue).
Ethical approval has been granted by the Ethics Committee of the University of Urbino Carlo Bo (Minutes No. 96, July 24, 2025).
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's enrollment of 216 is above the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →Liaquat University of Medical & Health Sciences is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Bactoblis® Evol (Streptococcus salivarius Evol12®)
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.
Other: Placebo
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.
Also known as: Placebo (matching orodispersible tablet)
Reduction in recurrence of acute febrile adenotonsillitis
Number of febrile adenotonsillitis episodes occurring during the 6-month study period. Outcomes will be assessed using the Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K), completed during each febrile episode to record symptom severity and quality of life.
Time frame: 6 months
Reduction in duration of acute febrile adenotonsillitis episodes
Duration (in days) of each febrile adenotonsillitis episode during the 6-month study period, assessed using the Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) completed by caregivers during illness episodes.
Time frame: 6 months
Occurrence of adenotonsillar symptoms
Number of adenotonsillar symptom episodes (fever ≥38°C, sore throat, tonsil exudate, difficulty swallowing, earache, acute otitis media, fatigue or joint pain, swollen lymph nodes, or cough) reported by parents or guardians using an episode symptom card.
Time frame: 6 months
Duration of adenotonsillar symptoms
Total duration (in days) of adenotonsillar symptom episodes (fever ≥38°C, sore throat, tonsil exudate, difficulty swallowing, earache, acute otitis media, fatigue or joint pain, swollen lymph nodes, or cough) reported by parents or guardians using an episode symptom card.
Time frame: 6 months
Change in sleep-related quality of life assessed by the Obstructive Sleep Apnea-18 (OSA-18) questionnaire
Assessment of changes in sleep-related quality of life using the Obstructive Sleep Apnea-18 (OSA-18) questionnaire completed by the parent or legal guardian. The OSA-18 total score ranges from 18 to 126, with higher scores indicating a worse sleep-related quality of life. The questionnaire evaluates symptoms and impact across five domains: sleep disturbance, physical suffering, emotional distress, daytime problems, and caregiver concerns.
Time frame: 6 months
Number of school days missed
Total number of school days missed due to adenotonsillar infections during the study period, as recorded in the daily symptom card.
Time frame: 6 months
Number of antibiotic treatments prescribed for adenotonsillar infections
otal number of antibiotic treatment courses prescribed for adenotonsillar infections during the 6-month study period, as reported by parents or legal guardians on the episode symptom card.
Time frame: 6 months
Duration of antibiotic treatment for adenotonsillar infections
Total duration (in days) of antibiotic treatment courses prescribed for adenotonsillar infections during the 6-month study period, as reported by parents or legal guardians on the episode symptom card.
Time frame: 6 months
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Liaquat University of Medical & Health Sciences