Antibiotic-associated Loose/Watery Stools
Conditions
Brief summary
To assess the tolerability and effect of a probiotic product, when co-administered with antibiotics, on the incidence and duration of loose/watery stools following the antibiotic treatment in children.
Interventions
DIETARY_SUPPLEMENTProbiotic capsules
DIETARY_SUPPLEMENTPlacebo capsules
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
Inclusion criteria
1. Children at the age of 1-11 years that have been ordinated to start antibiotic treatment except for penicillin. 2. Possibility to initiate the probiotic treatment within 24 hours after the first dose of the antibiotic treatment. 3. Children whose parents or legal caregivers have signed the informed consent to participate in the study.
Exclusion criteria
1. Chronic intestinal disease. 2. Current immunodeficiency or immunosuppressive treatment. 3. Chronic or acute diarrhoeal disease. 4. Use of laxatives the week before inclusion in the study. 5. Antibiotic treatment for the last four weeks before inclusion in the study. 6. Known hypersensitivity to any of the ingredients in the probiotic product or the placebo \[potato starch, silicon dioxide, capsule (hypromellose, water) ± bacterial culture\]. 7. Intake of any probiotic products for the last two weeks before inclusion in the study. 8. Patient requiring hospitalisation. Lack of parents´/legal guardians´ informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of the incidence of loose/watery stools following antibiotic treatment in children. | 19-24 days |
Countries
Poland
Outcome results
None listed