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Effect of Bifidobacterium Breve PRL2020 (an Amoxicillin-clavulanate-resistant Strain) on Gastrointestinal Symptoms and Gut Microbiota Composition in Children Treated With Amoxicillin or Amoxicillin/Clavulanate

NCT05840588 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2025-11-21

No results posted yet for this study

Summary

Amoxicillin or Amoxicillin/Clavulanic acid antibiotic therapy has been shown to be associated with disrupting the microbiota population particularly Bifidobacterium, which may have further GI clinical implications.

The present randomized clinical trial is aimed to assess if probiotic Bifidobacterium breve PRL2020 (Brevicillin®) can help modulate the Bifidobacterium population and its clinical implications after antibiotic Amoxicillin or Amoxicillin/Clavulanic acid antibiotic therapy.

Conditions

Interventions

DRUG

Antibiotic Treatment

Antibiotic Amoxicillin or Amoxicillin/Clavulanic acid

DIETARY_SUPPLEMENT

Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) treatment

Probiotic Bifidobacterium breve PRL2020 (Brevicillin®)

Sponsors & Collaborators

  • University of Urbino "Carlo Bo"

    collaborator OTHER

  • Liaquat University of Medical & Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2025-03-31
Completion
2025-04-18

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT05840588 on ClinicalTrials.gov