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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT03445260
Eligibility Criteria:
Inclusion Criteria:
* Men and women 18 years of age or older
* Diagnosed with a resectable type of gastrointestinal cancer (e.g. cancers of the gallbladder, liver, pancreas, stomach, small intestine, colon and rectum) for which an elective operation is planned (resection vs. palliative procedure).
* Patients with distant metastasis are eligible for the study.
* Patients who are lactose intolerant are also eligible for the study because the amount of lactose in ISOlution and PreCovery is minimal (trace).
Exclusion Criteria:
* Malabsorption syndrome (e.g. chronic pancreatitis)
* Cannot tolerate oral intake (e.g. gastric outlet obstruction or delayed gastric emptying)
* Organ failure (liver, kidney); end stage liver disease with a Child Pugh Score ≥ B or end stage renal disease defined as stages 3 and 4 with a glomerular filtration rate between 30-59 for stage 3 and 15-29 for stage 4.
* Inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematous, Crohn's disease and ulcerative colitis
* Patients currently on steroids
* Poorly controlled type 1 or 2 diabetes mellitus
* Female patients who are pregnant and/or lactating
* Galactosemia
* Ongoing infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03445260
Study Brief:
Protocol Section:
NCT03445260