Effect of Lactobacillus Reuteri DSM 17938 to Prevent Antibiotic-associated Diarrhea in Children

Summary

Recent studies showed that intestinal microbiota consist more than thousand bacteria, and these microorganisms play the role as balance and continuity of the anatomical and functional integrity gastrointestinal tract. Chronic diseases, nutritional factors, lifestyle factors and medications including antibiotics changes the host microbiota in short or long-term period. Antibiotics are the most commonly used drugs in pediatrics routine practice. Although frequency and severity of side effects alter the choice of drug, mild complications may be taken into consideration for treatment by a physician in the profit and loss balance. Our study group (PROBAGE Working Group) have been recently showed that Lactobacillus reuteri DSM 17938 reduced the duration of diarrhea in children with acute infectious diarrhea, and are safe and well-tolerated. In this study the investigators aim to evaluate the potential effect of Lactobacillus reuteri DSM 17938 on the prevention of antibiotic associated diarrhea in children.

Conditions

• Antibiotic Associated Diarrhea

Interventions

DRUG

Lactobacillus reuteri DSM 17938

Comparison the effects of Lactobacillus reuteri DSM 17938 and placebo for prevention of antibiotic associated diarrhea and also plan to compare the duration of treatment for on efficacy.

DRUG

Placebo

Comparison the effects of Lactobacillus reuteri DSM 17938 and placebo for prevention of antibiotic associated diarrhea and also plan to compare the duration of treatment for on

DRUG

Amoxicillin-Clavulanic Acid

All study patients will received amoxicillin-clavulanic acid at the dose of 50-90 mg/kg/day.

Sponsors & Collaborators

• Hacettepe University

  collaborator OTHER

• Acıbadem University School of Medicine

  collaborator OTHER

• Umraniye Education and Research Hospital

  collaborator OTHER_GOV

• Sisli Hamidiye Etfal Training and Research Hospital

  collaborator OTHER

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  collaborator OTHER

• Ege University Medical School

  collaborator OTHER

• Yuzuncu Yıl University

  collaborator OTHER

• Goztepe Training and Research Hospital

  collaborator OTHER

• Erzurum Regional Training & Research Hospital

  collaborator OTHER_GOV

• Namik Kemal University

  collaborator OTHER

• Eskisehir Osmangazi University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-01

Primary Completion

2020-07-01

Completion

2020-12-01

Countries

• Turkey (Türkiye)

Study Locations