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).
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.
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.
Liaquat University of Medical & Health Sciences
Lead sponsor
University of Urbino "Carlo Bo"
Collaborator