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NCT Number: NCT07234448

Evaluation of the Use of a Probiotic Containing Bifidobacterium Breve PRL2020 in Oral Drops in Preventing Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid Antibiotic Use

This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of the probiotic Bifidobacterium breve PRL2020 (Brevicillin® gocce) in preventing gastrointestinal side effects associated with antibiotic therapy using amoxicillin or amoxicillin/clavulanic acid in pediatric patients aged 0-12 years. Participants will be randomized 1:1 to receive either the probiotic supplement or placebo during standard antibiotic treatment for 6-10 days, followed by a post-treatment observation period up to day 15 without probiotic or placebo administration. The primary objective is to assess the reduction in the incidence of antibiotic-associated diarrhea (AAD).

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Key information

Conditions

Antibiotic-associated Diarrhea

Age range

0 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Urbino "Carlo Bo"

Urbino, 61029, Italy

About this study

Antibiotic therapy with amoxicillin or amoxicillin/clavulanic acid is widely prescribed in pediatric populations but is frequently associated with gastrointestinal adverse effects, particularly diarrhea. These effects are linked to disruption of the gut microbiota and a reduction in bifidobacterial populations. Bifidobacterium breve PRL2020 is a probiotic strain with demonstrated intrinsic, non-transferable resistance to these antibiotics and has been developed to mitigate antibiotic-induced dysbiosis.

This study is a multicenter, prospective, randomized, double-blind, placebo-controlled, non-profit trial conducted in pediatric centers across Italy. The study aims to evaluate the clinical efficacy and safety of Bifidobacterium breve PRL2020 in reducing the incidence and severity of antibiotic-associated diarrhea (AAD) in children receiving amoxicillin or amoxicillin/clavulanic acid.

A total of 1100 participants (550 per group) will be enrolled. Participants will be randomized 1:1 to receive either Brevicillin® gocce (5 drops 2-3 times daily, containing 5 billion CFU of B. breve PRL2020 per dose) or matching placebo only during antibiotic therapy (6-10 days). After completion of antibiotic treatment, participants will enter a follow-up period until day 15 without probiotic or placebo administration.

The primary outcome is the incidence of AAD, defined as ≥3 diarrheal episodes in one day during antibiotic treatment (Bristol Stool Scale 5-7).

Secondary outcomes include the incidence and duration of diarrhea, daily bowel movements, stool consistency, gastrointestinal and extra-intestinal symptoms (such as nausea, vomiting, abdominal pain), treatment compliance, and adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female participants aged 0-12 years.
  • Undergoing antibiotic therapy with amoxicillin or amoxicillin/clavulanic acid.
  • Parent or legal guardian provides written informed consent.

Exclusion criteria

  • Use of antibiotic therapy within 4 weeks prior to enrolment.
  • Use of other probiotic products or lactic acid bacteria during the study.
  • Pre-existing diarrhea within 4 weeks prior to enrolment.
  • Chronic inflammatory bowel disease.
  • Immunodeficiency.
  • Lack of parental or legal guardian consent to participate in the study.

Treatment and study plan

Brevicillin® gocce (Bifidobacterium breve PRL2020)

Dietary Supplement

Brevicillin® gocce is a probiotic dietary supplement in oily drops containing the bacterial strain Bifidobacterium breve PRL2020 (LMG S-32458). Each 5-drop dose contains approximately 5 billion live cells. The supplement is administered orally 2-3 times per day, in parallel with antibiotic therapy (amoxicillin or amoxicillin/clavulanic acid), for 6-10 days only (during the antibiotic course).

After completion of antibiotic therapy, participants enter a follow-up period until day 15 without probiotic administration. The product is manufactured by PharmExtracta S.p.A., Pontenure, Italy.

Placebo (matching oil drops)

Other

The placebo is a formulation identical in appearance, packaging, and administration schedule to Brevicillin® gocce but without the Bifidobacterium breve PRL2020 strain. It is administered orally 2-3 times per day only during the antibiotic treatment period (6-10 days).

After antibiotic completion, participants enter a follow-up period until day 15 without placebo administration.

Primary outcomes

  1. Incidence of Antibiotic-Associated Diarrhea (AAD)

    Time frame: 15 days

    Evaluation of the efficacy of Bifidobacterium breve PRL2020 (Brevicillin® gocce) in reducing the incidence of antibiotic-associated diarrhea (AAD), defined as ≥3 diarrheal episodes within one day of antibiotic treatment, with stool consistency corresponding to types 5-7 on the Bristol Stool Scale. Data will be collected through a daily diary completed by the parent or legal guardian.

Secondary outcomes

  1. Incidence of children with at least one episode of diarrhea

    Time frame: 15 days

    Number of participants experiencing at least one episode of diarrhea during the study period, as recorded in the daily diary.

  2. Number of daily defecations

    Time frame: 15 days

    Average number of daily bowel movements recorded by the parent or guardian during the study period, using the child's daily diary.

  3. Number of days with diarrhea

    Time frame: 15 days

    Total number of days in which diarrhea occurs during the observation period, recorded by the parent or guardian.

  4. Stool consistency

    Time frame: 15 days

    Assessment of stool consistency using the Bristol Stool Scale (BSS) to evaluate changes in bowel habits during and after antibiotic treatment.

  5. Gastrointestinal and extra-intestinal symptoms

    Time frame: 15 days

    Evaluation of symptoms related to antibiotic use, including abdominal pain, nausea, and vomiting, assessed from daily diary entries completed by the parent or guardian

  6. Treatment compliance

    Time frame: 15 days

    Assessment of adherence to the probiotic or placebo regimen, graded by the pediatrician on a scale from "poor" to "excellent" at the end of the study period.

  7. Adverse events

    Time frame: 15 days

    Documentation and evaluation of any adverse events reported during treatment and follow-up, as recorded in the child's daily diary and verified by the study physician.

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Collaborators

  • University of Urbino "Carlo Bo"

Registry information

Official study title

Evaluation of the Use of a Probiotic Containing Bifidobacterium Breve PRL2020 in Oral Drops in Preventing Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid Antibiotic Use: a Multicentre, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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