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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT06764056
Eligibility Criteria:
Inclusion Criteria:
* Body mass index between 30 and 50 kg/m2;
* Stade 2 or 3 (S2 or S3) hepatic steatosis with or without liver fibrosis.
Exclusion Criteria:
* Type 1 diabetes diagnosis;
* Alcohol consumption exceeding recommendations \[\>140 g/week (women) and \>210 g/week (men)\];
* Known chronic hepatic disease non-steatotic at the entry of the study (Wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency, viral hepatitis, auto-immune hepatitis, etc.);
* Pharmacological treatment targeting obesity active or ended in the last 3 months;
* Bariatric surgery;
* Gastro-intestinal pathologies (GI cancers, IBD, etc.);
* Capsulated probiotics consumption;
* Antibiotic treatment in the last 3 months;
* Pregnancy;
* Cirrhosis diagnosis (hepatic decompensation).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06764056
Study Brief:
Protocol Section:
NCT06764056