This study aims to evaluate the efficacy and safety of the probiotic Bifidobacterium breve PRL2020 in preventing gastrointestinal and extra-intestinal side effects caused by Amoxicillin or Amoxicillin/Clavulanic Acid in pediatric patients. The study will compare a treatment group receiving the probiotic alongside antibiotics with a control group receiving antibiotics alone. The primary focus is on reducing antibiotic-induced intestinal discomfort through microbiota modulation.
Age 3 to 12 years
Requiring antibiotic therapy with Amoxicillin or Amoxicillin/Clavulanic Acid
Ability to comply with the study protocol (parents/caregivers must complete symptom diaries)
Use of any antibiotic therapy within 3 months before study enrollment
Known gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease)
History of chronic diarrhea or constipation
Allergy to probiotics or study interventions
Liaquat University of Medical & Health Sciences
Lead sponsor
Università degli Studi dell'Insubria
Collaborator