Actively Recruiting
Evaluation of the Efficacy of Streptococcus Salivarius Evol12® in the Reduction of Recurrent Adenotonsillitis in Children
Led by Liaquat University of Medical & Health Sciences · Updated on 2025-11-19
200
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
L
Liaquat University of Medical & Health Sciences
Lead Sponsor
U
University of Urbino "Carlo Bo"
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Efficacy of Streptococcus Salivarius Evol12® in the Reduction of Recurrent Adenotonsillitis in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female children aged 3 to 11 years.
- History of 3 documented episodes of acute adenotonsillitis within the previous 12 months, each with fever of at least 38C.
- Signed and accepted informed consent from a parent or legal guardian.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Università di Urbino Carlo Bo
Urbino, PU (Pesaro E Urbino), Italy, 61029
Actively Recruiting
Research Team
D
Davide Sisti, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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