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

Probi AB

Status

Completed

Conditions

Antibiotic-associated Diarrhea

Treatments

Dietary Supplement: Probiotics

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02722993

ProGastro Kids 16

Details and patient eligibility

About

To assess the effect of a probiotic product, when co-administered with antibiotics, on gastrointestinal symptoms following antibiotic treatment in children.

Enrollment

117 patients

Sex

All

Ages

1 to 11 years old

Volunteers

No Healthy Volunteers

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.