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:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT04791956
Eligibility Criteria:
Inclusion Criteria:
* Child is healthy at the time of pre-examination
* Child was born on term or preterm (≥ 32 weeks of gestation)
* Child is aged 6-12 months at the time of pre-examination (for preterm born children (32-37 weeks of gestation), corrected age will be applied)
* Normal growth (weight and length for age between 10th and 90th percentiles, Fenton and Kim 2013)
* Child receives at least one meal per day as complementary feeding
* Child and legal guardian are able and willing to follow the study instructions
* Child is suitable for participation in the study according to the investigator/physician/study personnel
* Written informed consent is given by parent or legal guardian
Exclusion Criteria:
* No legal guardian's command of any local language
* Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc.
* Other metabolic or renal abnormalities or psychomotor retardation (e.g. hypotonia)
* Child has allergy to cow's milk protein or lactose intolerance
* Child has been or is currently breast-fed more than once daily (6 weeks before intervention)
* Child has mostly loose or watery stools in ≥ 50% of defecations
* Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
* Use of laxatives or pre- or probiotic supplements in the previous 4 weeks before intervention
* Child is currently involved or will be involved in another clinical or food study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
12 Months
Study:
NCT04791956
Study Brief:
Protocol Section:
NCT04791956