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.
Age 3 to 12 years
Requiring antibiotic therapy with Amoxicillin or Amoxicillin/Clavulanic Acid
Ability to comply with the study protocol (parents/caregivers must complete symptom diaries)
Use of any antibiotic therapy within 3 months before study enrollment
Known gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease)
History of chronic diarrhea or constipation
Allergy to probiotics or study interventions
Parallel
Bifidobacterium breve PRL2020 (Brevicillin®)
Dietary supplementProbiotic 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
DrugTreatment of Amoxicillin or Amoxicillin/Clavulanic Acid as per medical prescription.
Change in Antibiotic-Associated Gastrointestinal Symptoms
Evaluation of changes in gastrointestinal symptoms (diarrhea, bloating, abdominal pain, constipation) using the Bristol Stool Scale and a VAS symptom scale (0-7 points). Participants will document symptoms in a daily symptom diary. A significant reduction in symptoms in the probiotic group compared to the control group will indicate efficacy.
Safety and Tolerability of Bifidobacterium breve PRL2020
Assessment of adverse events or intolerance to the probiotic supplementation.
Incidence of Antibiotic-Associated Diarrhea (AAD)
Proportion of participants developing diarrhea (≥3 loose stools/day for ≥2 days) as per WHO definition.
Changes in Stool Consistency and Frequency
Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS), a validated 7-point scale where: Score 1 = Separate hard lumps (severe constipation), Score 7 = Watery, entirely liquid stools (severe diarrhea). Higher scores indicate looser stool consistency and a worse outcome in cases of diarrhea. Lower scores indicate constipation. Stool frequency will be recorded as the number of bowel movements per day.
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Liaquat University of Medical & Health Sciences
Lead sponsor
Università degli Studi dell'Insubria
Collaborator
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