Evaluation of Bifidobacterium Breve PRL2020 in Preventing Antibiotic-Associated Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid

NCT06850714 | Not Yet Recruiting DMC

• 1 other identifier: CESU/77/06.09.2023
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of the probiotic Bifidobacterium breve PRL2020 in preventing gastrointestinal and extra-intestinal side effects caused by Amoxicillin or Amoxicillin/Clavulanic Acid in pediatric patients. The study will compare a treatment group receiving the probiotic alongside antibiotics with a control group receiving antibiotics alone. The primary focus is on reducing antibiotic-induced intestinal discomfort through microbiota modulation.

Conditions

Antibiotic Side Effect

Outcome Measures

Primary Outcomes (1)

• Change in Antibiotic-Associated Gastrointestinal Symptoms

  Evaluation of changes in gastrointestinal symptoms (diarrhea, bloating, abdominal pain, constipation) using the Bristol Stool Scale and a VAS symptom scale (0-7 points). Participants will document symptoms in a daily symptom diary. A significant reduction in symptoms in the probiotic group compared to the control group will indicate efficacy.

  15 days (treatment duration + follow-up)

Secondary Outcomes (3)

• Safety and Tolerability of Bifidobacterium breve PRL2020

  15 days

• Incidence of Antibiotic-Associated Diarrhea (AAD)

  15 days

• Changes in Stool Consistency and Frequency

  15 days

Study Arms (2)

Probiotic + Antibiotic Group (Probiotic Group)

EXPERIMENTAL

Participants in this group will receive Amoxicillin or Amoxicillin/Clavulanic Acid as prescribed by their physician, and a probiotic as add-on for the duration of antibiotic therapy (6-10 days).

Dietary Supplement: Bifidobacterium breve PRL2020 (Brevicillin®); Drug: Amoxicillin or Amoxicillin/Clavulanic Acid

Antibiotic-Only Group (Control Group)

ACTIVE COMPARATOR

Participants in this group will receive only Amoxicillin or Amoxicillin/Clavulanic Acid as per medical prescription.

Drug: Amoxicillin or Amoxicillin/Clavulanic Acid

Interventions

Bifidobacterium breve PRL2020 (Brevicillin®) DIETARY_SUPPLEMENT

Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) at a dose of 20 billion CFU per day (one stick in the morning and one in the evening).

Also known as: Brevicillin®, PharmExtracta S.p.A.

Probiotic + Antibiotic Group (Probiotic Group)

Amoxicillin or Amoxicillin/Clavulanic Acid DRUG

Treatment of Amoxicillin or Amoxicillin/Clavulanic Acid as per medical prescription.

Antibiotic-Only Group (Control Group); Probiotic + Antibiotic Group (Probiotic Group)

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3 to 12 years
• Requiring antibiotic therapy with Amoxicillin or Amoxicillin/Clavulanic Acid
• Ability to comply with the study protocol (parents/caregivers must complete symptom diaries)

You may not qualify if:

• Use of any antibiotic therapy within 3 months before study enrollment
• Known gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease)
• History of chronic diarrhea or constipation
• Allergy to probiotics or study interventions
• Any immunocompromised state

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• Università degli Studi dell'Insubria: collaborator

Study Sites (1)

Medicine & Technological Innovation Dept. University of Insubria

Varese, Italy

Location

Related Publications (6)

• 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.

  PMID: 11821511 BACKGROUND

• 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.

  PMID: 17449881 BACKGROUND

• 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.

  PMID: 1929247 BACKGROUND

• 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.

  PMID: 34398323 BACKGROUND

• 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.

  PMID: 33483308 BACKGROUND

• Di Pierro F, Campedelli I, De Marta P, Fracchetti F, Del Casale A, Cavecchia I, Matera M, Cazzaniga M, Bertuccioli A, Guasti L, Zerbinati N. Bifidobacterium breve PRL2020: Antibiotic-Resistant Profile and Genomic Detection of Antibiotic Resistance Determinants. Microorganisms. 2023 Jun 24;11(7):1649. doi: 10.3390/microorganisms11071649.

  PMID: 37512822 BACKGROUND

MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental medicine

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: February 27, 2025
• Study Start: February 23, 2025
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)