Evaluation of Bifidobacterium Breve PRL2020 in Preventing Antibiotic-Associated Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid

Liaquat University of Medical & Health Sciences

Status: Not yet enrolling

Conditions: Antibiotic Side Effect

Treatments: Drug: Amoxicillin or Amoxicillin/Clavulanic Acid; Dietary Supplement: Bifidobacterium breve PRL2020 (Brevicillin®)

Study type: Interventional

Funder types: Other

Identifiers

NCT06850714

CESU/77/06.09.2023

Details and patient eligibility

About

This study aims to evaluate the efficacy and safety of the probiotic Bifidobacterium breve PRL2020 in preventing gastrointestinal and extra-intestinal side effects caused by Amoxicillin or Amoxicillin/Clavulanic Acid in pediatric patients. The study will compare a treatment group receiving the probiotic alongside antibiotics with a control group receiving antibiotics alone. The primary focus is on reducing antibiotic-induced intestinal discomfort through microbiota modulation.

Full description

Antibiotic therapy, particularly with Amoxicillin and Amoxicillin/Clavulanic Acid, is widely used to treat bacterial infections in children. However, these antibiotics often disrupt the gut microbiota, leading to gastrointestinal side effects such as diarrhea, bloating, abdominal pain, and constipation. This imbalance can reduce the abundance of beneficial bacterial species, including bifidobacteria, potentially leading to long-term gastrointestinal dysbiosis.

This observational, non-profit study aims to evaluate the efficacy and safety of Bifidobacterium breve PRL2020 (Brevicillin®), a probiotic strain with demonstrated resistance to Amoxicillin and Amoxicillin/Clavulanic Acid. Prior research has shown that this strain has a high minimum inhibitory concentration (MIC) of 32-64 μg/mL, making it a promising candidate for preventing antibiotic-associated gut microbiota alterations.

The study will recruit 800 pediatric patients (ages 3-12 years) who require antibiotic therapy for infections. Participants will be randomized into two groups:

Probiotic Group: Receives Bifidobacterium breve PRL2020 (20 billion CFU per day) alongside antibiotic treatment.

Control Group: Receives antibiotics only, without probiotic supplementation. The primary outcome will be the evaluation of gastrointestinal symptoms and stool consistency using the Bristol Stool Scale and a VAS symptom scale (0-7 points) over a 15-day period (treatment duration + follow-up). The secondary outcome will assess the safety and tolerability of the probiotic intervention.

Clinical data will be collected via a daily symptom diary maintained by caregivers, including frequency of bowel movements, stool quality, presence of abdominal pain, and other potential side effects. Statistical analysis will determine whether Bifidobacterium breve PRL2020 significantly reduces antibiotic-associated gastrointestinal disturbances compared to the control group.

This study is expected to provide critical insights into the role of probiotic supplementation in mitigating antibiotic-induced dysbiosis, potentially shaping future guidelines for pediatric antibiotic therapy.

Enrollment: 800 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 3 to 12 years
• Requiring antibiotic therapy with Amoxicillin or Amoxicillin/Clavulanic Acid
• Ability to comply with the study protocol (parents/caregivers must complete symptom diaries)

Exclusion criteria

• Use of any antibiotic therapy within 3 months before study enrollment
• Known gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease)
• History of chronic diarrhea or constipation
• Allergy to probiotics or study interventions
• Any immunocompromised state

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Probiotic + Antibiotic Group (Probiotic Group)

Experimental group

Description:

Participants in this group will receive Amoxicillin or Amoxicillin/Clavulanic Acid as prescribed by their physician, and a probiotic as add-on for the duration of antibiotic therapy (6-10 days).

Treatment:

Dietary Supplement: Bifidobacterium breve PRL2020 (Brevicillin®)

Drug: Amoxicillin or Amoxicillin/Clavulanic Acid

Antibiotic-Only Group (Control Group)

Active Comparator group

Description:

Participants in this group will receive only Amoxicillin or Amoxicillin/Clavulanic Acid as per medical prescription.

Treatment:

Drug: Amoxicillin or Amoxicillin/Clavulanic Acid