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

Bacterial Infections Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840588
• Other study ID #: LUMHS/REC/180
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Liaquat University of Medical & Health Sciences
• Contact: Dr. Ikram Ujjan, MBBS, PhD
• Phone: +92 300 3002993
• Email: ikramujjan[@]lumhs.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Drug:
• Antibiotic Treatment
Antibiotic Amoxicillin or Amoxicillin/Clavulanic acid

Dietary Supplement:
• Probiotic Bifidobacterium breve PRL2020 treatment
Probiotic Bifidobacterium breve PRL2020

Locations

Country	Name	City	State
Pakistan	Liaquat University Hospital	Jamshoro

Sponsors (1)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of any Gastrointestinal upset	Safety or tolerability of the treatments in both groups	3 weeks
Secondary	Probiotic colonization rate	Assessment of the probiotic colonization rate in both groups particularly effect on Bifidobacterium cluster	3 weeks