Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT02722993
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
11 Years
Study:
NCT02722993
Study Brief:
Protocol Section:
NCT02722993