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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT00031135
Eligibility Criteria:
Inclusion criteria:
* Underlying pathology may include, but is not limited to: short bowel syndrome, chronic pancreatitis, pancreatic pseudocysts, pseudo-obstruction, enterocutaneous fistula, entero-enteric fistula, or malabsorption syndrome.
* Requirement for TPN to supply greater than 85 percent of nutritional needs for at least 16 weeks.
Exclusion criteria:
* Not receiving lipid emulsion with TPN regimen
* Albumin less than 2.5 g/L
* Renal failure requiring hemo- or peritoneal dialysis
* Hepatic failure (PT greater than 2 times control)
* Diabetes
* Hepatitis C
* AIDS
* Concurrent hospitalization for organ transplantation or rejection treatment
* Concurrent cholinergic medication
* Positive pregnancy test
* Refusal to use an acceptable method of birth control
* Ethanol abuse
* More than 40 kcal/kg/day ideal body weight
* Obesity with ensuing weight loss
* Use of IV tetracycline, valproic acid, corticosteroids, methotrexate, or amiodarone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
74 Years
Study:
NCT00031135
Study Brief:
Protocol Section:
NCT00031135