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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT05909228
Eligibility Criteria:
Inclusion criteria are as follows:
In order to be eligible to participate in this study, a patient must meet all of the following criteria at time of inclusion:
1. Consent provided
2. Age \< 18 years
3. Suffering from IF needing PN providing at least 25% of calories for ≥6 weeks
4. Medically stable with no acute changes in condition requiring hospitalization, or other intervention at home (for at least 3 months).
For healthy controls the inclusion criteria are as follows:
1. Consent provided
2. Age \< 18 years.
A patient who meets any of the following criteria will be excluded from participation in this study:
1. On PN for \< 6 weeks
2. Suffering from an acute clinical event, for example gastroenteritis, colds and flu
3. Suffering from sepsis on antibiotics
4. On medication known to affect bone metabolism, for example steroids
5. Having a history of fracture within the last 12 months.
For healthy controls, the exclusion criteria are as follows:
1. Any condition known to affect bone health (chronic disease, bone disease, history of malignancy, radiotherapy, steroid use, mental or physical disability)
2. A positive history of fractures within the past 2 years
3. Poor growth (weight- and height-for-age below - 2 or above + 2 standard deviation score using the WHO growth charts).
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
18 Years
Study:
NCT05909228
Study Brief:
Protocol Section:
NCT05909228