Effect of Bifidobacterium Breve PRL2020 (an Amoxicillin-clavulanate-resistant Strain) on Gastrointestinal Symptoms and Gut Microbiota Composition in Children Treated With Amoxicillin or Amoxicillin/Clavulanate

NCT05840588 | Completed

• 1 other identifier: 77_6settembre2023
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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 (Brevicillin®) can help modulate the Bifidobacterium population and its clinical implications after antibiotic Amoxicillin or Amoxicillin/Clavulanic acid antibiotic therapy.

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (2)

• Incidence of antibiotic-associated diarrhea (AAD)

  Assessment of diarrhea occurring during antibiotic treatment with amoxicillin or amoxicillin/clavulanic acid. AAD will be counted starting from a single episode of diarrhea and not only after three or more episodes in one day, differing from the standard AAD definition.

  7-10 days (according to antibiotic prescription)

• Incidence of gastrointestinal symptoms other than diarrhea

  Evaluation of gastrointestinal symptoms related to antibiotic therapy, including constipation, nausea, vomiting, abdominal cramps, bloating, and loss of appetite. These will be recorded daily by parents or legal guardians during the antibiotic course.

  7-10 days (according to antibiotic prescription)

Secondary Outcomes (3)

• Change in gut microbiota diversity following probiotic and antibiotic treatment

  7-10 days (according to antibiotic prescription)

• Tolerability of probiotic treatment

  7-10 days (according to antibiotic prescription)

• Adherence to probiotic treatment

  7-10 days (according to antibiotic prescription)

Study Arms (2)

Probiotic Bifidobacterium breve PRL2020 (Brevicillin®)

EXPERIMENTAL

Patients in this arm will receive Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) (20 billion CFU) 2 sticks/day for 7-10 days (according to antibiotic prescription)in addition to the antibiotic Amoxicillin or Amoxicillin/Clavulanic acid (antibiotic doses: 2-3/day according to physician prescription).

Drug: Antibiotic Treatment; Dietary Supplement: Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) treatment

Control

ACTIVE COMPARATOR

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

Drug: Antibiotic Treatment

Interventions

Antibiotic Treatment DRUG

Antibiotic Amoxicillin or Amoxicillin/Clavulanic acid

Control; Probiotic Bifidobacterium breve PRL2020 (Brevicillin®)

Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) treatment DIETARY_SUPPLEMENT

Probiotic Bifidobacterium breve PRL2020 (Brevicillin®)

Probiotic Bifidobacterium breve PRL2020 (Brevicillin®)

Eligibility Criteria

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

You may qualify if:

• Children aged between 3-12 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.

You may not qualify if:

• Presence of neurological, oncological (also past), malformative, and/or autoimmune pathology
• Suspected or presumed allergy to the substance contained in the probiotic formula
• Using any type of probiotic product in the three months before the enrollment or during the trial
• Lack of parental consent to participate in the study

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• University of Urbino "Carlo Bo": collaborator

Study Sites (1)

Università di Urbino Carlo Bo

Urbino, PU (Pesaro E Urbino), 61029, Italy

Location

Related Publications (7)

• 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

• 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

• 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.

  PMID: 32582117 BACKGROUND

• 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.

  PMID: 31172651 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: May 3, 2023
• Study Start: November 6, 2023
• Primary Completion: March 31, 2025
• Study Completion: April 18, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)