Efficacy and Safety of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders.

Launched by PROBI AB · Sep 9, 2013

Keywords

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Eligibility criteria

• • 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.