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

Last updated: April 21, 2023
Sponsor: Liaquat University of Medical & Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bacterial Infections

Treatment

Probiotic Bifidobacterium breve PRL2020 treatment

Antibiotic Treatment

Clinical Study ID

NCT05840588
LUMHS/REC/180
  • Ages 4-12
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children aged between 4-12 years, of either gender, with a bacterial infection and theuse of antibiotic therapy with Amoxicillin or Amoxicillin/clavulanic acid under aPhysician's prescription.
  • Informed written consent from legal guardian

Exclusion

Exclusion Criteria:

  • Use of antibiotics within 3 months prior to enrolment

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Probiotic Bifidobacterium breve PRL2020 treatment
Phase:
Study Start date:
April 10, 2023
Estimated Completion Date:
December 31, 2023

Study Description

Treatment with Amoxicillin or Amoxicillin/Clavulanic acid is one of the most common antibiotic therapies used against various infections both in children and adults. These antibiotics can create an imbalance in the intestinal microbiota, altering its structure with a reduction in bacterial richness and, more specifically, in the abundance of bifidobacteria. This opened the window for further evaluations of the effect of this antibiotic combination on the composition of gut microbiota. The alteration can lead to intestinal symptoms such as pain, bloating, abdominal distension, flatulence, diarrhea, and constipation. In study by L. Mancabelli et al. (2021), Bifidobacterium breve PRL2020 has shown greatest resistance to Amoxicillin and Amoxicillin/Clavulanic acid. Currently available scientific data, however, have not yet analyzed the ability of B. breve PRL2020 to counteract the reduction of bifidobacteria that may occur in the human gut during the antibiotic therapy with Amoxicillin or Amoxicillin/Clavulanic acid, and neither its ability to avoid the consequent clinical relapse.

The purpose of this randomized, controlled, prospective, single-center, non-profit study will be to evaluate the efficacy and safety of the administration of Bifidobacterium breve PRL2020 in pediatric patients (> 4 years of age), treated with the antibiotic Amoxicillin or Amoxicillin/Clavulanic acid, in the improvement of the symptoms due to the pharmacological treatment and in the contrast of the fall of the Bifidobacterium cluster.

Connect with a study center

  • Liaquat University Hospital

    Jamshoro,
    Pakistan

    Active - Recruiting

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