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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 oppdatert 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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

1024

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 sekund til 12 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: 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 komparator: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Antibiotic-Associated Diarrhea (AAD)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of children with at least one episode of diarrhea
Tidsramme: 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
Tidsramme: 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
Tidsramme: 15 days

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Liaquat University of Medical & Health Sciences

Samarbeidspartnere

University of Urbino "Carlo Bo"

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

16. november 2026

Primær fullføring (Antatt)

1. mars 2027

Studiet fullført (Antatt)

1. mars 2027

Datoer for studieregistrering

Først innsendt

6. november 2026

Først innsendt som oppfylte QC-kriteriene

10. november 2026

Først lagt ut (Faktiske)

13. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 188_2ottobre2026_DROPS AAD_Sis

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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