Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders
ClinicalTrials.gov ID
NCT02722993
Lead Sponsor
Probi ABINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
117Actual
Last Update Posted
Sep 26, 2018Actual
Start Date
Feb 3, 2016Actual
Primary Completion Date
May 8, 2017Actual
Completion Date
May 8, 2017Actual
Brief Summary
To assess the effect of a probiotic product, when co-administered with antibiotics, on gastrointestinal symptoms following antibiotic treatment in children.
Antibiotic-associated Diarrhea
Probiotics
Placebo
Ages Eligible for Study
Child (0-17)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children at the age of 1-11 years that have been prescribed antibiotic treatment.
Problems with loose stools during earlier antibiotic treatments.
Children whose parents or legal caregivers have signed the informed consent to participate in the study.
Exclusion Criteria:
Chronic intestinal disease, immunodeficiency or immunosuppressive treatment.
Chronic or acute diarrheal disease.
Use of laxatives the week before inclusion in the study.
Antibiotic treatment for the last four weeks before inclusion in the study.
Intake of probiotic products for the last two weeks before inclusion in the study.
Known hypersensitivity to any of the ingredients in the probiotic product or the placebo (potato starch ± bacterial culture that may contain traces of soy).