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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2025-04-18

Brief Summary

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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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Detailed Description

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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.

Conditions

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Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Probiotic Bifidobacterium breve PRL2020 (Brevicillin®)

Patients in this arm will receive Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) (20 billion CFU) 2 sticks/day for 7-10 days (according to antibiotic prescription)in addition to the antibiotic Amoxicillin or Amoxicillin/Clavulanic acid (antibiotic doses: 2-3/day according to physician prescription).

Group Type EXPERIMENTAL

Antibiotic Treatment

Intervention Type DRUG

Antibiotic Amoxicillin or Amoxicillin/Clavulanic acid

Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) treatment

Intervention Type DIETARY_SUPPLEMENT

Probiotic Bifidobacterium breve PRL2020 (Brevicillin®)

Control

Patients in this arm will receive only antibiotic Amoxicillin or Amoxicillin/Clavulanic acid.

Group Type ACTIVE_COMPARATOR

Antibiotic Treatment

Intervention Type DRUG

Antibiotic Amoxicillin or Amoxicillin/Clavulanic acid

Interventions

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Antibiotic Treatment

Antibiotic Amoxicillin or Amoxicillin/Clavulanic acid

Intervention Type DRUG

Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) treatment

Probiotic Bifidobacterium breve PRL2020 (Brevicillin®)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No