CompletedNot Applicable

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

Italy121 participantsStarted 2023-11-06

Plain-language 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.

Who can participate

Age range3 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged between 3-12 years, of either gender, with a bacterial infection and the use of antibiotic therapy with Amoxicillin or Amoxicillin/clavulanic acid under a Physician's prescription. Exclusion Criteria: * Presence of neurological, oncological (also past), malformative, and/or autoimmune pathology * Suspected or presumed allergy to the substance contained in the probiotic formula * Using any type of probiotic product in the three months before the enrollment or during the trial * Lack of parental consent to participate in the study

What they're measuring

Incidence of antibiotic-associated diarrhea (AAD)

Timeframe: 7-10 days (according to antibiotic prescription)

Incidence of gastrointestinal symptoms other than diarrhea

Timeframe: 7-10 days (according to antibiotic prescription)

Trial details

NCT IDNCT05840588

SponsorLiaquat University of Medical & Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31