MedTrace Logo

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

NCT06850714 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-03-04

No results posted yet for this study

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.

Conditions

  • Antibiotic Side Effect

Interventions

DIETARY_SUPPLEMENT

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).

DRUG

Amoxicillin or Amoxicillin/Clavulanic Acid

Treatment of Amoxicillin or Amoxicillin/Clavulanic Acid as per medical prescription.

Sponsors & Collaborators

  • Università degli Studi dell'Insubria

    collaborator OTHER

  • Liaquat University of Medical & Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-23
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06850714 on ClinicalTrials.gov