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Evaluation of Bifidobacterium Breve PRL2020 in Preventing Antibiotic-Associated Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid
Sponsor: Liaquat University of Medical & Health Sciences
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.
Official title: Evaluation of the Use of Bifidobacterium Breve PRL2020 in Preventing Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid Antibiotic Use: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
3 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2025-02-23
Completion Date
2025-12-31
Last Updated
2025-03-04
Healthy Volunteers
No
Conditions
Interventions
Bifidobacterium breve PRL2020 (Brevicillin®)
Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) at a dose of 20 billion CFU per day (one stick in the morning and one in the evening).
Amoxicillin or Amoxicillin/Clavulanic Acid
Treatment of Amoxicillin or Amoxicillin/Clavulanic Acid as per medical prescription.
Locations (1)
Medicine & Technological Innovation Dept. University of Insubria
Varese, Italy