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

Launched by LIAQUAT UNIVERSITY OF MEDICAL & HEALTH SCIENCES · Feb 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a specific probiotic called Bifidobacterium breve PRL2020 can help prevent some side effects that children might experience when taking antibiotics like Amoxicillin or Amoxicillin/Clavulanic Acid. The goal is to see if taking this probiotic along with antibiotics can reduce stomach discomfort and other related issues. The study will involve two groups of children: one group will receive the probiotic with their antibiotics, while the other group will only receive the antibiotics.

To be eligible for this study, children must be between 3 and 12 years old and need to take either Amoxicillin or Amoxicillin/Clavulanic Acid. Parents or caregivers will need to keep track of the child's symptoms through diaries. However, children with certain gastrointestinal diseases, allergies to probiotics, or those who have taken antibiotics in the past three months won’t be able to participate. This study is not yet recruiting participants, but it aims to help improve the way antibiotics are tolerated in children.

Gender

ALL

Eligibility criteria

• 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