Overview

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

Status:
Completed
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eskisehir Osmangazi University
Collaborators:
Acıbadem University Medical School
Acıbadem University School of Medicine
Bezmialem University Medical School
Ege University Medical School
Erzurum Regional Training & Research Hospital
Fırat University Medical School
Goztepe Training and Research Hospital
Hacettepe University
Namik Kemal University
Okmeydani Training and Research Hospital
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sisli Etfal Training & Research Hospital
Sisli Hamidiye Etfal Training and Research Hospital
Umraniye Education and Research Hospital
Yuzuncu Yıl University
Treatments:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Antibiotics, Antitubercular
Clavulanic Acid
Clavulanic Acids
Criteria
Inclusion Criteria:

• Children receiving amoxicilline-clavulanic acid (50-90 mg/kg/day, twice daily) due to
acute otitis media or acute sinusitis

Exclusion Criteria:

- Receiving antibiotic and/or probiotic, 8 weeks before the study

- Chronic gastrointestinal system disorders

- Congenital anomalies

- Chronic diseases

- Chemotherapy and radiotherapy

- Pregnancy