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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT03407833
Eligibility Criteria:
Inclusion Criteria:
\- Scheduled for upper endoscopy, colonoscopy or metabolic and bariatric surgery, or liver transplantation at Vanderbilt University Medical Center.
Additional inclusion criteria for individuals scheduled for metabolic and bariatric surgery: Obese, ≥ 40 kg/m2 or ≥ 35 kg/m2 + one comorbidity (type 2 diabetes \[fasting blood glucose ≥ 120 mg/dL; HbA1C ≥ 6.5%\]; fatty liver disease, hypertension, cardiovascular disease, hyperlipidemia)
Additional inclusion criteria for individuals scheduled for liver transplantation: diagnosis of nonalcoholic liver disease or nonalcoholic steatohepatitis
Exclusion Criteria:
* Known history of intestinal diseases including, but not limited to, inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) and celiac sprue.
* Smoking \>7 cigarettes per day
* Malabsorptive syndromes
* Pregnant or breastfeeding
Additional exclusion criteria for patients undergoing endoscopy/colonoscopy:
* Recent history of malignancy (\<5 years ago)
* Previous lap band surgery
* Established renal disease
Additional exclusion criteria for patients undergoing bariatric surgery:
* Previous lap band, sleeve gastrectomy, or gastric bypass surgery
* Recent history of malignancy (\< 5 years ago)
* Established organ dysfunction
Additional exclusion criteria for patients undergoing liver transplantation:
* Previous lap band, sleeve gastrectomy, or gastric bypass surgery
* Alpha 1 anti-trypsin disease, Wilson's disease, viral hepatitis, alcoholic liver disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03407833
Study Brief:
Protocol Section:
NCT03407833