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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT02550860
Eligibility Criteria:
Inclusion Criteria:
* Patient with sever chronic intestinal disease requiring long term parenteral nutrition
* Receiving home lipid containing parenteral nutrition (LCPN), regardless of currently infused intravenous fat emulsion
* With a stable dose of LCPN for at least 1 month at recruitment time
* Administered at least 4 days a week through central venous access, with at least 150 mL of lipid per parenteral nutrition bag with lipid.
* Age \>18
* Being available for 2 medical consultations in a 6 month period
* Who gave its written informed consent to participate to the study and without legal protection
* Social security coverage
Exclusion Criteria:
* Lesser expected parenteral nutrition length than duration for the entire trial
* Dermatological criteria : History of skin disease (atopic dermatitis, psoriasis) or evolving skin disease, broken or inflamed skin on the TEWL measurement site, Use of topical creams on the TEWL measurement site, Skin or systemic allergy (asthma)
* Contraindication to one of the selected intravenous fat emulsion: Severe dyslipidemia; Uncontrolled diabetes; Sepsis; Severe hepatic impairment; Major blood clotting disorders; Egg protein, soybean, peanut or fish hyper sensibility; Serum creatinine clearance \< 30 ml/min
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02550860
Study Brief:
Protocol Section:
NCT02550860