Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05840588
Status:
RECRUITING
Last Update Posted:
2023-05-03
First Post:
2023-04-01
Brief Title:
Evaluation of the Impact of an Amoxicillin and AmoxicillinClavulanic Acid Resistant Probiotic on Key Clinical Outcomes in Children Treated With Amoxicillin or AmoxicillinClavulanic Acid
Sponsor:
Liaquat University of Medical Health Sciences
Organization:
Liaquat University of Medical Health Sciences
Study Overview
Official Title:
Evaluation of the Impact of an Amoxicillin and AmoxicillinClavulanic Acid Resistant Probiotic on Key Clinical Outcomes in Children Treated With Amoxicillin or AmoxicillinClavulanic Acid
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROACRE
Brief Summary:
Amoxicillin or AmoxicillinClavulanic 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 AmoxicillinClavulanic acid antibiotic therapy
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 AmoxicillinClavulanic acid antibiotic therapy
Detailed Description:
Treatment with Amoxicillin or AmoxicillinClavulanic 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 AmoxicillinClavulanic 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 AmoxicillinClavulanic 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 AmoxicillinClavulanic acid in the improvement of the symptoms due to the pharmacological treatment and in the contrast of the fall of the Bifidobacterium cluster
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 AmoxicillinClavulanic acid in the improvement of the symptoms due to the pharmacological treatment and in the contrast of the fall of the Bifidobacterium cluster
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None