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AzTrials

Bacterial InfectionsNCT05840588

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

A study testing Antibiotic Treatment and Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) treatment in people with Bacterial Infections, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 3 to 12 years
Conditions the study is for
Bacterial Infections
What is being tested?
Antibiotic Treatment and Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteItaly
Study dates
6 Nov 2023to 18 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Università di Urbino Carlo Bo

    Urbino, PU (Pesaro E Urbino), 61029

Other trials in Italy

About this study

Official title: 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: Results of a Pediatric, Multicenter, Randomized, Controlled, Prospective Study

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.

Read the 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 (untreated group), prospective, multicentre, single-center, non-profit study will be to evaluate the efficacy and safety of the administration of Bifidobacterium breve PRL2020 (Brevicillin®) in pediatric patients (> 3 -12 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.

Being tested
Antibiotic Treatment, Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) treatment
Medical subject headings
Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antibiotic TreatmentDrug

    Antibiotic Amoxicillin or Amoxicillin/Clavulanic acid

  • Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) treatmentDietary supplement

    Probiotic Bifidobacterium breve PRL2020 (Brevicillin®)

Study groups in NCT05840588
Study groupRoleWhat they receive
Probiotic Bifidobacterium breve PRL2020 (Brevicillin®)ExperimentalPatients 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).
Receives: Drug: Antibiotic Treatment; Dietary Supplement: Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) treatment
ControlActive comparatorPatients in this arm will receive only antibiotic Amoxicillin or Amoxicillin/Clavulanic acid.
Receives: Drug: Antibiotic Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7-10 days (according to antibiotic prescription)

  2. 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.

    Measured: 7-10 days (according to antibiotic prescription)

Secondary outcomes (3)

  1. Change in gut microbiota diversity following probiotic and antibiotic treatment

    Change in gut microbiota composition and diversity assessed by 16S rRNA sequencing of stool samples collected during and after the treatment period. Alpha diversity (Shannon index) and relative abundance of Bifidobacterium genus will be calculated and compared between groups.

    Measured: 7-10 days (according to antibiotic prescription)

  2. Tolerability of probiotic treatment

    Number of participants rated as having "good" or "excellent" tolerability to probiotic treatment, as assessed by the physician at the end of antibiotic therapy. Tolerability will be evaluated based on clinical observation and parental report of side effects (e.g., nausea, abdominal discomfort, rash).

    Measured: 7-10 days (according to antibiotic prescription)

  3. Adherence to probiotic treatment

    Percentage of participants who completed ≥80% of the prescribed probiotic doses during the antibiotic treatment period, as assessed by returned product count and parental report.

    Measured: 7-10 days (according to antibiotic prescription)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start6 Nov 2023
  3. Primary completion31 Mar 2025
  4. Study completion18 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05840588
Sponsor's protocol ID
77_6settembre2023
Status last verified
Nov 2025
First submitted
1 Apr 2023
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33483308

  • 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.

    PubMed 11821511

  • 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.

    PubMed 17449881

  • 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.

    PubMed 1929247

  • 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.

    PubMed 34398323

  • 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.

    PubMed 32582117

  • 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.

    PubMed 31172651

Questions about this trial

What is this clinical trial studying?

A study testing Antibiotic Treatment and Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) treatment in people with Bacterial Infections, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of antibiotic-associated diarrhea (AAD) (time frame: 7-10 days (according to antibiotic prescription)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05840588, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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