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Antibiotic Side EffectNCT06850714

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

A study testing Bifidobacterium breve PRL2020 (Brevicillin®) and Amoxicillin or Amoxicillin/Clavulanic Acid in people with Antibiotic Side Effect, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 12 years
Conditions the study is for
Antibiotic Side Effect
What is being tested?
Bifidobacterium breve PRL2020 (Brevicillin®) and Amoxicillin or Amoxicillin/Clavulanic Acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
1 siteItaly
Study dates
23 Feb 2025to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site

  • Medicine & Technological Innovation Dept. University of Insubria

    Varese

    Dr. Francesco Di Pierro, PhD, f.dipierro@vellejaresearch.com

Other trials in Italy

About this study

Official title: Evaluation of the Use of Bifidobacterium Breve PRL2020 in Preventing Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid Antibiotic Use: A Randomized Controlled Trial

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.

Read the detailed description

Antibiotic therapy, particularly with Amoxicillin and Amoxicillin/Clavulanic Acid, is widely used to treat bacterial infections in children. However, these antibiotics often disrupt the gut microbiota, leading to gastrointestinal side effects such as diarrhea, bloating, abdominal pain, and constipation. This imbalance can reduce the abundance of beneficial bacterial species, including bifidobacteria, potentially leading to long-term gastrointestinal dysbiosis.

This observational, non-profit study aims to evaluate the efficacy and safety of Bifidobacterium breve PRL2020 (Brevicillin®), a probiotic strain with demonstrated resistance to Amoxicillin and Amoxicillin/Clavulanic Acid. Prior research has shown that this strain has a high minimum inhibitory concentration (MIC) of 32-64 μg/mL, making it a promising candidate for preventing antibiotic-associated gut microbiota alterations.

The study will recruit 800 pediatric patients (ages 3-12 years) who require antibiotic therapy for infections. Participants will be randomized into two groups:

Probiotic Group: Receives Bifidobacterium breve PRL2020 (20 billion CFU per day) alongside antibiotic treatment.

Control Group: Receives antibiotics only, without probiotic supplementation. The primary outcome will be the evaluation of gastrointestinal symptoms and stool consistency using the Bristol Stool Scale and a VAS symptom scale (0-7 points) over a 15-day period (treatment duration + follow-up). The secondary outcome will assess the safety and tolerability of the probiotic intervention.

Clinical data will be collected via a daily symptom diary maintained by caregivers, including frequency of bowel movements, stool quality, presence of abdominal pain, and other potential side effects. Statistical analysis will determine whether Bifidobacterium breve PRL2020 significantly reduces antibiotic-associated gastrointestinal disturbances compared to the control group.

This study is expected to provide critical insights into the role of probiotic supplementation in mitigating antibiotic-induced dysbiosis, potentially shaping future guidelines for pediatric antibiotic therapy.

Being tested
Bifidobacterium breve PRL2020 (Brevicillin®), Amoxicillin or Amoxicillin/Clavulanic Acid

What participants receive

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

  • Bifidobacterium breve PRL2020 (Brevicillin®)Dietary supplement

    Also called Brevicillin®, PharmExtracta S.p.A.

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

  • Amoxicillin or Amoxicillin/Clavulanic AcidDrug

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

Study groups in NCT06850714
Study groupRoleWhat they receive
Probiotic + Antibiotic Group (Probiotic Group)ExperimentalParticipants 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).
Receives: Dietary Supplement: Bifidobacterium breve PRL2020 (Brevicillin®); Drug: Amoxicillin or Amoxicillin/Clavulanic Acid
Antibiotic-Only Group (Control Group)Active comparatorParticipants in this group will receive only Amoxicillin or Amoxicillin/Clavulanic Acid as per medical prescription.
Receives: Drug: Amoxicillin or Amoxicillin/Clavulanic Acid

What is being measured

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

  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.

    Measured: 15 days (treatment duration + follow-up)

Secondary outcomes (3)

  1. Safety and Tolerability of Bifidobacterium breve PRL2020

    Assessment of adverse events or intolerance to the probiotic supplementation.

    Measured: 15 days

  2. Incidence of Antibiotic-Associated Diarrhea (AAD)

    Proportion of participants developing diarrhea (≥3 loose stools/day for ≥2 days) as per WHO definition.

    Measured: 15 days

  3. Changes in Stool Consistency and Frequency

    Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS), a validated 7-point scale where:

    Score 1 = Separate hard lumps (severe constipation), Score 7 = Watery, entirely liquid stools (severe diarrhea). Higher scores indicate looser stool consistency and a worse outcome in cases of diarrhea. Lower scores indicate constipation.

    Stool frequency will be recorded as the number of bowel movements per day.

    Measured: 15 days

Timeline

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

  1. First posted27 Feb 2025
  2. Study start23 Feb 2025 (estimated)
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06850714
Sponsor's protocol ID
CESU/77/06.09.2023
Status last verified
Feb 2025
First submitted
22 Feb 2025
Last updated
4 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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

  • 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.

    PubMed 37512822

Questions about this trial

What is this clinical trial studying?

A study testing Bifidobacterium breve PRL2020 (Brevicillin®) and Amoxicillin or Amoxicillin/Clavulanic Acid in people with Antibiotic Side Effect, 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Mar 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Antibiotic-Associated Gastrointestinal Symptoms (time frame: 15 days (treatment duration + follow-up)). 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 NCT06850714, which also lists 6 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 4 Mar 2025.

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