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

2026年11月10日 更新者：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).

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

1024

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1秒 至 12年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
膳食补充剂：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.
安慰剂比较：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.
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of Antibiotic-Associated Diarrhea (AAD)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Incidence of children with at least one episode of diarrhea
大体时间：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
大体时间：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
大体时间：15 days

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Liaquat University of Medical & Health Sciences

合作者

University of Urbino "Carlo Bo"

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月16日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2027年3月1日

研究注册日期

首次提交

2026年11月6日

首先提交符合 QC 标准的

2026年11月10日

首次发布 (实际的)

2026年11月13日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月10日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 188_2ottobre2026_DROPS AAD_Sis

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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