NCT05840588

Evaluation of the Impact of an Amoxicillin and Amoxicillin/Clavulanic Acid Resistant Probiotic on Key Clinical Outcomes in Children Treated With Amoxicillin or Amoxicillin/Clavulanic Acid

Name: Clinical Trial NCT05840588
Creator: Liaquat University of Medical & Health Sciences
Keywords: Bacterial Infections, Antibiotic Treatment, drug, clinical trial, Pakistan

Liaquat University of Medical & Health Sciences·ClinicalTrials.gov·drugRecruiting

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Study focus

Disease/Condition: Bacterial Infections
Drug/Device/Intervention: Antibiotic Treatment
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Liaquat University of Medical & Health Sciences
Location: Jamshoro, Pakistan

Timeline & enrollment

Phase: N/A
Start date: Apr 10, 2023
End date: Dec 31, 2023
Enrollment: 300 participants

Primary outcome

Incidence of any Gastrointestinal upset

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 can help modulate the Bifidobacterium population and its clinical implications after antibiotic Amoxicillin or Amoxicillin/Clavulanic acid antibiotic therapy.

ICD-10 classifications

Bacterial infection, unspecifiedBacterial, viral and other infectious agentsOther bacterial intestinal infectionsOther bacterial diseasesOther specified bacterial intestinal infections

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05840588
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05840588 through Pure Global AI's free database. This phase not specified trial is sponsored by Liaquat University of Medical & Health Sciences and is currently Recruiting. The study focuses on Bacterial Infections. Target enrollment is 300 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.