Antibiotic-associated Diarrhea
Conditions
Brief summary
To assess the effect of a probiotic product, when co-administered with antibiotics, on gastrointestinal symptoms following antibiotic treatment in children.
Interventions
DIETARY_SUPPLEMENTProbiotics
DIETARY_SUPPLEMENTPlacebo
Sponsors
Probi AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 11 Years
Healthy volunteers
No
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). * Patient requiring hospitalisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of loose/watery stools | 19-26 days |
Countries
Poland
Outcome results
None listed