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).

NCT Number	NCT07234448
Lead Sponsor	Liaquat University of Medical & Health Sciences Collaborators: University of Urbino "Carlo Bo"
Conditions	Antibiotic-associated Diarrhea
Enrollment	1,100 participants
Start Date	2025-12-01
Primary Completion	2026-07-03 (estimated)
Study Completion	2026-07-03 (estimated)
Updated on ClinicalTrials.gov	2026-07-07