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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 (PROACRE)

Primary Purpose

Bacterial Infections

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Antibiotic Treatment
Probiotic Bifidobacterium breve PRL2020 treatment
Sponsored by
Liaquat University of Medical & Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Liaquat University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Probiotic Bifidobacterium breve PRL2020

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Incidence of any Gastrointestinal upset
Safety or tolerability of the treatments in both groups

Secondary Outcome Measures

Probiotic colonization rate
Assessment of the probiotic colonization rate in both groups particularly effect on Bifidobacterium cluster

Full Information

First Posted
April 1, 2023
Last Updated
April 21, 2023
Sponsor
Liaquat University of Medical & Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05840588
Brief Title
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
Acronym
PROACRE
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaquat University of Medical & Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic Bifidobacterium breve PRL2020
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive only antibiotic Amoxicillin or Amoxicillin/Clavulanic acid.
Intervention Type
Drug
Intervention Name(s)
Antibiotic Treatment
Intervention Description
Antibiotic Amoxicillin or Amoxicillin/Clavulanic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic Bifidobacterium breve PRL2020 treatment
Intervention Description
Probiotic Bifidobacterium breve PRL2020
Primary Outcome Measure Information:
Title
Incidence of any Gastrointestinal upset
Description
Safety or tolerability of the treatments in both groups
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Probiotic colonization rate
Description
Assessment of the probiotic colonization rate in both groups particularly effect on Bifidobacterium cluster
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Ikram Ujjan, MBBS, PhD
Phone
+92 300 3002993
Email
ikramujjan@lumhs.edu.pk
Facility Information:
Facility Name
Liaquat University Hospital
City
Jamshoro
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Amjad Khan, DPhil
Email
amjadkhan@lumhs.edu.pk
First Name & Middle Initial & Last Name & Degree
Ikram Ujjan, MBBS, PhD
Phone
+92 300 3002993
Email
ikramujjan@lumhs.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33483308
Citation
Mancabelli L, Mancino W, Lugli GA, Argentini C, Longhi G, Milani C, Viappiani A, Anzalone R, Bernasconi S, van Sinderen D, Ventura M, Turroni F. Amoxicillin-Clavulanic Acid Resistance in the Genus Bifidobacterium. Appl Environ Microbiol. 2021 Mar 11;87(7):e03137-20. doi: 10.1128/AEM.03137-20. Print 2021 Mar 11.
Results Reference
background
PubMed Identifier
11821511
Citation
Bartlett JG. Clinical practice. Antibiotic-associated diarrhea. N Engl J Med. 2002 Jan 31;346(5):334-9. doi: 10.1056/NEJMcp011603. No abstract available.
Results Reference
background
PubMed Identifier
17449881
Citation
Salvo F, Polimeni G, Moretti U, Conforti A, Leone R, Leoni O, Motola D, Dusi G, Caputi AP. Adverse drug reactions related to amoxicillin alone and in association with clavulanic acid: data from spontaneous reporting in Italy. J Antimicrob Chemother. 2007 Jul;60(1):121-6. doi: 10.1093/jac/dkm111. Epub 2007 Apr 21.
Results Reference
background
PubMed Identifier
1929247
Citation
Caron F, Ducrotte P, Lerebours E, Colin R, Humbert G, Denis P. Effects of amoxicillin-clavulanate combination on the motility of the small intestine in human beings. Antimicrob Agents Chemother. 1991 Jun;35(6):1085-8. doi: 10.1128/AAC.35.6.1085.
Results Reference
background
PubMed Identifier
34398323
Citation
Yang L, Bajinka O, Jarju PO, Tan Y, Taal AM, Ozdemir G. The varying effects of antibiotics on gut microbiota. AMB Express. 2021 Aug 16;11(1):116. doi: 10.1186/s13568-021-01274-w.
Results Reference
background
PubMed Identifier
32582117
Citation
Liu L, Wang Q, Lin H, Das R, Wang S, Qi H, Yang J, Xue Y, Mao D, Luo Y. Amoxicillin Increased Functional Pathway Genes and Beta-Lactam Resistance Genes by Pathogens Bloomed in Intestinal Microbiota Using a Simulator of the Human Intestinal Microbial Ecosystem. Front Microbiol. 2020 Jun 4;11:1213. doi: 10.3389/fmicb.2020.01213. eCollection 2020.
Results Reference
background
PubMed Identifier
31172651
Citation
Duranti S, Lugli GA, Milani C, James K, Mancabelli L, Turroni F, Alessandri G, Mangifesta M, Mancino W, Ossiprandi MC, Iori A, Rota C, Gargano G, Bernasconi S, Di Pierro F, van Sinderen D, Ventura M. Bifidobacterium bifidum and the infant gut microbiota: an intriguing case of microbe-host co-evolution. Environ Microbiol. 2019 Oct;21(10):3683-3695. doi: 10.1111/1462-2920.14705. Epub 2019 Jun 20.
Results Reference
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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

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