Clinical Trial

Evaluation of Bifidobacterium Breve PRL2020 in Preventing Antibiotic-Associated Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid

Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated March 4, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-02-22.
Trial Details
NCT Number NCT06850714
Lead Sponsor Liaquat University of Medical & Health Sciences
Collaborators: Università degli Studi dell'Insubria
Conditions Antibiotic Side Effect
Enrollment 800 participants
Start Date 2025-02-23
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-04