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).
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.
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.
Parallel
Brevicillin® gocce (Bifidobacterium breve PRL2020)
Dietary supplementBrevicillin® 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 interventionThe 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.
Incidence of Antibiotic-Associated Diarrhea (AAD)
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.
Incidence of children with at least one episode of diarrhea
Number of participants experiencing at least one episode of diarrhea during the study period, as recorded in the daily diary.
Number of daily defecations
Average number of daily bowel movements recorded by the parent or guardian during the study period, using the child's daily diary.
Number of days with diarrhea
Total number of days in which diarrhea occurs during the observation period, recorded by the parent or guardian.
Stool consistency
Assessment of stool consistency using the Bristol Stool Scale (BSS) to evaluate changes in bowel habits during and after antibiotic treatment.
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Liaquat University of Medical & Health Sciences
Lead sponsor
University of Urbino "Carlo Bo"
Collaborator
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