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

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

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, 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.

Official Title
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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

Conditions
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Bacterial Infections

Intervention / Treatment
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* Drug: Antibiotic Treatment
* Dietary Supplement: Probiotic Bifidobacterium breve PRL2020 treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged between 4-12 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. Informed written consent from legal guardian Exclusion Criteria: Use of antibiotics within 3 months prior to enrolment

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Bifidobacterium breve PRL2020<br>Patients in this arm will receive Probiotic Bifidobacterium breve PRL2020 (20 billion CFU) 2 sticks/day for 10 days in addition to the antibiotic Amoxicillin or Amoxicillin/Clavulanic acid. | Drug: Antibiotic Treatment<br>* Antibiotic Amoxicillin or Amoxicillin/Clavulanic acid<br>Dietary Supplement: Probiotic Bifidobacterium breve PRL2020 treatment<br>* Probiotic Bifidobacterium breve PRL2020<br>|
| Active Comparator: Control<br>Patients in this arm will receive only antibiotic Amoxicillin or Amoxicillin/Clavulanic acid. | Drug: Antibiotic Treatment<br>* Antibiotic Amoxicillin or Amoxicillin/Clavulanic acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of any Gastrointestinal upset | Safety or tolerability of the treatments in both groups | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probiotic colonization rate | Assessment of the probiotic colonization rate in both groups particularly effect on Bifidobacterium cluster | 3 weeks |