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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT04282551
Eligibility Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria, as considered by a medical doctor:
* Written informed consent
* Aged 1-3 years
* Children that meet the Rome IV criteria for functional constipation
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Children who suffer from any other GI complaints than functional constipation, known structural GI abnormalities, or previous GI surgery
* Any condition that would make it unsafe for the child to participate.
* Children with clinically significant cardiac, vascular, liver, pulmonary, psychiatric disorders, severe renal insufficiency, human immunodeficiency virus, acquired immunodeficiency syndrome, hepatitis B or C or known abnormalities of haematology, urinalysis, or blood biochemistry
* Children who are allergic to cow's milk or fish
* Use of antibiotics or other medicines or food supplements, and breast milk-feeding, 4 weeks prior to the study, except for the allowed escape medication
* Children that participate in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
3 Years
Study:
NCT04282551
Study Brief:
Protocol Section:
NCT04282551