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Probiotic Bifidobacterium Breve PRL2020 in Oral Drops in Preventing Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid Antibiotic Use

10 november 2026 uppdaterad av: Dr. Amjad Khan, Liaquat University of Medical & Health Sciences

Assessment of the Impact of an Amoxicillin/Clavulanic Acid-resistant Probiotic on the Reduction of AAD (Antibiotic-Associated Diarrhoea) in Children Treated With Amoxicillin/Clavulanic Acid or Amoxicillin: a Multicentre, Randomised, Placebo-controlled Clinical Trial.

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).

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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 1024 participants 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.

Studietyp

Interventionell

Inskrivning (Beräknad)

1024

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Italien
      • Alessandria, Italien, 15121
        • GROSSO CATERINA Studio medico - Spalto Marengo 92
        • Kontakt:
      • Alessandria, Italien, 15121
        • VALARAUDI PIERA Studio medico - Via Galimberti 25
        • Kontakt:
      • Busto Arsizio, Italien, 21052
        • MORGANTI GIANFRANCO Studio medico - Via Rossini Gioachino 9
        • Kontakt:
      • Frosinone, Italien, 03100
        • MARIANI PAOLO Studio medico - VIA AMERICA LATINA 135
        • Kontakt:
      • Genova, Italien, 16129
        • POGGI ELENA Studio medico - Via Montevideo 8
        • Kontakt:
      • Messina, Italien, 98123
        • BARBALACE ANDREA Studio medico - Via Nino Bixio 76
        • Kontakt:
      • Messina, Italien, 98123
        • INFERRERA RAMONA Studio medico - Via Trieste 19
        • Kontakt:
      • Roma, Italien, 00156
        • PACCHIAROTTI ALESSIA Studio medico - VIA FIUMINATA 4
        • Kontakt:
      • Torino, Italien, 10137
        • ROVELLI ILARIA Studio medico - Via Baltimora 86
        • Kontakt:
      • Varese, Italien, 21100
        • COLLI GIOVANNI studio medico privato - via Caracciolo 54
        • Kontakt:
    • Catanzaro
      • Lamezia Terme, Catanzaro, Italien, 88046
        • NERO ANNA MARIA Centro Salute Galattica - Via Giovanni Gronchi, 1
        • Kontakt:
    • Chieti
      • Casoli, Chieti, Italien, 66043
        • ANTONELLI LUCIETTA Studio medico - Vico Montaniera 27
        • Kontakt:
    • Como
      • Cantù, Como, Italien, 22063
        • OMETTO MARIANGELA studio pediatrico associato - via Al Monte 4
        • Kontakt:
    • Frosinone
      • Anagni, Frosinone, Italien, 03012
        • D'AVERSA IRENE Studio medico - VIALE REGINA MARGHERITA 7
        • Kontakt:
      • Anagni, Frosinone, Italien, 03012
        • NOTO CRISTIAN Studio medico - VIA TARTARALTA DI SOTTO 25
        • Kontakt:
    • Padova
      • Piazzola sul Brenta, Padova, Italien, 35016
        • NARDINI FLAVIA studio medico - Via Portico della Tessitura 3/1
        • Kontakt:
    • Palermo
      • Bagheria, Palermo, Italien
        • MANCUSO GIUSEPPINA Studio medico - Via De Spuches 14
        • Kontakt:
    • Perugia
      • Bastia umbra, Perugia, Italien, 06083
        • RASTELLI STEFANIA studio medico - Via Foligno 23
        • Kontakt:
      • Foligno, Perugia, Italien, 06034
        • CAMPUS MARIA GIULIA studio medico - Via Aspromonte SNC
        • Kontakt:
    • Venezia
      • Mira, Venezia, Italien, 30034
        • SATARIANO IRENE studio medico - Largo S.Luca 2
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 sekund till 12 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Patients of either sex
  • Age ≤ 12 years
  • Requirement to undergo antibiotic treatment with amoxicillin or amoxicillin/clavulanic acid

Exclusion Criteria:

  • Use of antibiotic therapy in the 4 weeks prior to enrolment in the study.
  • Use of other probiotic products or products containing lactic acid bacteria during the study period.
  • Presence of pre-existing diarrhoea in the 4 weeks prior to enrolment.
  • Presence of chronic inflammatory bowel disease.
  • Presence of immunodeficiency.
  • Failure to obtain informed consent from the parent or legal guardian for participation in the study.
  • Known allergy to the excipients in the formulation

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Brevicillin® gocce (Bifidobacterium breve PRL2020)

Participants will receive Brevicillin® gocce, a probiotic food supplement containing Bifidobacterium breve PRL2020 (LMG S-32458), alongside standard antibiotic therapy with amoxicillin or amoxicillin/clavulanic acid.

Dosage and administration: 5 drops, 2-3 times per day (depending on antibiotic dosing schedule), administered during the antibiotic treatment period (6-10 days). After completion of antibiotic therapy, participants will enter a follow-up period until day 15 without probiotic administration.
Kosttillskott: Brevicillin® gocce (Bifidobacterium breve PRL2020)

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-jämförare: Placebo

Participants will receive a placebo formulation matched in appearance, packaging, and dosing schedule to Brevicillin® gocce, administered alongside standard antibiotic therapy with amoxicillin or amoxicillin/clavulanic acid.

The placebo will be given at the same frequency (5 drops, 2-3 times per day) and duration as the experimental product during the antibiotic treatment period (6-10 days). After antibiotic completion, participants will enter a follow-up period until day 15 without placebo administration.
Övrig: Placebo (matching oil drops)

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of Antibiotic-Associated Diarrhea (AAD)
Tidsram: 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.
15 days

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of children with at least one episode of diarrhea
Tidsram: 15 days

Number of participants experiencing at least one episode of diarrhea during the study period, as recorded in the daily diary.
15 days
Number of daily defecations
Tidsram: 15 days

Average number of daily bowel movements recorded by the parent or guardian during the study period, using the child's daily diary.
15 days
Number of days with diarrhea
Tidsram: 15 days

Total number of days in which diarrhea occurs during the observation period, recorded by the parent or guardian.
15 days
Stool consistency
Tidsram: 15 days

Assessment of stool consistency using the Bristol Stool Scale (BSS) to evaluate changes in bowel habits during and after antibiotic treatment.
15 days
Abdominal pain During and After Antibiotic Treatment
Tidsram: 15 days

Assessment of abdominal pain related to antibiotic use, as recorded in daily diary entries completed by the parent or guardian.
15 days
Nausea During and After Antibiotic Treatment
Tidsram: 15 days

Assessment of nausea related to antibiotic use, as recorded in daily diary entries completed by the parent or guardian.
15 days
Vomiting During and After Antibiotic Treatment
Tidsram: 15 days

Assessment of vomiting related to antibiotic use, as recorded in daily diary entries completed by the parent or guardian.
15 days
Treatment compliance
Tidsram: 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.
15 days
Adverse events
Tidsram: 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.
15 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Liaquat University of Medical & Health Sciences

Samarbetspartners

University of Urbino "Carlo Bo"

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

16 november 2026

Primärt slutförande (Beräknad)

1 mars 2027

Avslutad studie (Beräknad)

1 mars 2027

Studieregistreringsdatum

Först inskickad

6 november 2026

Först inskickad som uppfyllde QC-kriterierna

10 november 2026

Första postat (Faktisk)

13 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 188_2ottobre2026_DROPS AAD_Sis

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