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

10 novembre 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

1024

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 seconde à 12 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Complément alimentaire: 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.
Comparateur placebo: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of Antibiotic-Associated Diarrhea (AAD)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of children with at least one episode of diarrhea
Délai: 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
Délai: 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
Délai: 15 days

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Liaquat University of Medical & Health Sciences

Collaborateurs

University of Urbino "Carlo Bo"

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

16 novembre 2026

Achèvement primaire (Estimé)

1 mars 2027

Achèvement de l'étude (Estimé)

1 mars 2027

Dates d'inscription aux études

Première soumission

6 novembre 2026

Première soumission répondant aux critères de contrôle qualité

10 novembre 2026

Première publication (Réel)

13 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 188_2ottobre2026_DROPS AAD_Sis

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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