Not Yet RecruitingNot Applicable

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

Italy800 participantsStarted 2025-02-23

Plain-language 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.

Who can participate

Age range3 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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 * Any immunocompromised state

What they're measuring

Change in Antibiotic-Associated Gastrointestinal Symptoms

Timeframe: 15 days (treatment duration + follow-up)

Trial details

NCT IDNCT06850714

SponsorLiaquat University of Medical & Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Antibiotic Side Effect trials