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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT02158351
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, equal or over 18 years old
2. Eligible for Sleeve Gastrectomy for obesity with BMI 35-50 kg/m2
3. Eligible for Cholecystectomy for symptomatic gallstones and bright liver at ultrasounds
4. Alcohol consumption is less than 20 g/d
Exclusion Criteria:
1. Having liver disease of other etiology
2. Having advanced liver disease
3. Having abnormal coagulation or other reason contraindicating a Liver Biopsy
4. On regular intake of medications known to cause or exacerbate steatohepatitis or antibiotic, pre- or probiotics in the previous 3 months
5. Use of vitamin E or fish oil supplements in the previous 2 months
6. Alcohol consumption of more than 20 g/dl
7. Inflammatory bowel diseases
8. previous gastrointestinal surgery modifying the anatomy (prior to bariatric surgery)
9. Pregnancy or lactating state
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02158351
Study Brief:
Protocol Section:
NCT02158351