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Efficacy and Safety of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
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Ages Eligible for Study:
1 Year to 11 Years (Child)
Sexes Eligible for Study:
Children at the age of 1-11 years that have been ordinated to start antibiotic treatment except for penicillin.
Possibility to initiate the probiotic treatment within 24 hours after the first dose of the antibiotic treatment.
Children whose parents or legal caregivers have signed the informed consent to participate in the study.
Chronic intestinal disease.
Current immunodeficiency or immunosuppressive treatment.
Chronic or acute diarrhoeal disease.
Use of laxatives the week before inclusion in the study.
Antibiotic treatment for the last four weeks before inclusion in the study.
Known hypersensitivity to any of the ingredients in the probiotic product or the placebo [potato starch, silicon dioxide, capsule (hypromellose, water) ± bacterial culture].
Intake of any probiotic products for the last two weeks before inclusion in the study.
Patient requiring hospitalisation. Lack of parents´/legal guardians´ informed consent.