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
- Bacterial Infections
- Interventions
- Drug: Antibiotic TreatmentDietary Supplement: Probiotic Bifidobacterium breve PRL2020 treatment
- Registration Number
- NCT05840588
- Lead Sponsor
- Liaquat University of Medical & Health Sciences
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- Use of antibiotics within 3 months prior to enrolment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotic Bifidobacterium breve PRL2020 Antibiotic Treatment 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. Probiotic Bifidobacterium breve PRL2020 Probiotic Bifidobacterium breve PRL2020 treatment 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. Control Antibiotic Treatment Patients in this arm will receive only antibiotic Amoxicillin or Amoxicillin/Clavulanic acid.
- Primary Outcome Measures
Name Time Method Incidence of any Gastrointestinal upset 3 weeks Safety or tolerability of the treatments in both groups
- Secondary Outcome Measures
Name Time Method Probiotic colonization rate 3 weeks Assessment of the probiotic colonization rate in both groups particularly effect on Bifidobacterium cluster
Trial Locations
- Locations (1)
Liaquat University Hospital
🇵🇰Jamshoro, Pakistan