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NCT Number: NCT05840588

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

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.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università di Urbino Carlo Bo

Urbino, PU (Pesaro E Urbino), 61029, Italy

About this study

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 (untreated group), prospective, multicentre, single-center, non-profit study will be to evaluate the efficacy and safety of the administration of Bifidobacterium breve PRL2020 (Brevicillin®) in pediatric patients (> 3 -12 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic treatment

Drug

Antibiotic Amoxicillin or Amoxicillin/Clavulanic acid

Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) treatment

Dietary Supplement

Probiotic Bifidobacterium breve PRL2020 (Brevicillin®)

Primary outcomes

  1. Incidence of antibiotic-associated diarrhea (AAD)

    Time frame: 7-10 days (according to antibiotic prescription)

    Assessment of diarrhea occurring during antibiotic treatment with amoxicillin or amoxicillin/clavulanic acid.

    AAD will be counted starting from a single episode of diarrhea and not only after three or more episodes in one day, differing from the standard AAD definition.

  2. Incidence of gastrointestinal symptoms other than diarrhea

    Time frame: 7-10 days (according to antibiotic prescription)

    Evaluation of gastrointestinal symptoms related to antibiotic therapy, including constipation, nausea, vomiting, abdominal cramps, bloating, and loss of appetite. These will be recorded daily by parents or legal guardians during the antibiotic course.

Secondary outcomes

  1. Change in gut microbiota diversity following probiotic and antibiotic treatment

    Time frame: 7-10 days (according to antibiotic prescription)

    Change in gut microbiota composition and diversity assessed by 16S rRNA sequencing of stool samples collected during and after the treatment period. Alpha diversity (Shannon index) and relative abundance of Bifidobacterium genus will be calculated and compared between groups.

  2. Tolerability of probiotic treatment

    Time frame: 7-10 days (according to antibiotic prescription)

    Number of participants rated as having "good" or "excellent" tolerability to probiotic treatment, as assessed by the physician at the end of antibiotic therapy. Tolerability will be evaluated based on clinical observation and parental report of side effects (e.g., nausea, abdominal discomfort, rash).

  3. Adherence to probiotic treatment

    Time frame: 7-10 days (according to antibiotic prescription)

    Percentage of participants who completed ≥80% of the prescribed probiotic doses during the antibiotic treatment period, as assessed by returned product count and parental report.

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Collaborators

  • University of Urbino "Carlo Bo"

Registry information

Official study title

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: Results of a Pediatric, Multicenter, Randomized, Controlled, Prospective Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 3, 2023
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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