Evaluation of the Use of a Probiotic Containing Bifidobacterium Breve PRL2020 in Oral Drops in Preventing Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid Antibiotic Use

This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of the probiotic Bifidobacterium breve PRL2020 (Brevicillin® gocce) in preventing gastrointestinal side effects associated with antibiotic therapy using amoxicillin or amoxicillin/clavulanic acid in pediatric patients aged 0-12 years. Participants will be randomized 1:1 to receive either the probiotic supplement or placebo during standard antibiotic treatment for 6-10 days, followed by a post-treatment observation period up to day 15 without probiotic or placebo administration. The primary objective is to assess the reduction in the incidence of antibiotic-associated diarrhea (AAD).

Inclusion Criteria: * Male and female participants aged 0-12 years. * Undergoing antibiotic therapy with amoxicillin or amoxicillin/clavulanic acid. * Parent or legal guardian provides written informed consent. Exclusion Criteria: * Use of antibiotic therapy within 4 weeks prior to enrolment. * Use of other probiotic products or lactic acid bacteria during the study. * Pre-existing diarrhea within 4 weeks prior to enrolment. * Chronic inflammatory bowel disease. * Immunodeficiency. * Lack of parental or legal guardian consent to participate in the study.