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 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT04175392
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of NAFLD and/or NASH
* Subject aged 18 and older
* Non-pregnant - Self-reported
* Subject with decision making capacity to understand and consent to study procedures
* Ability to follow study related activities regarding medications, diet and exercise
Exclusion Criteria:
* Without diagnosis of NAFLD or NASH
* History of liver disease from other causes, including but not limited to hepatitis, autoimmune, alcohol use, fatty liver of pregnancy, Wilson's disease, primary or secondary hemochromatosis
* Patients aged less than 18 years
* Self-reported pregnant patients
* Inability to understand, follow and consent to study procedures
* Hepatic decompensation defined as gastrointestinal bleeding, ascites, hepatic encephalopathy
* Inability to engage in exercise
* Currently immunocompromised or taking immunosuppressive drugs
* Milk protein allergy
* Recent or active chemotherapy for malignancy
* Gastrointestinal malignancy
* Gastrointestinal disease such as Ulcerative Colitis, Crohn's Disease as these alter the microbiome
* Recent antibiotic therapy (within 6 months)
* Known allergy to probiotics
* History of major gastrointestinal surgery such as resection of the colon
* No concomitant use of probiotic from any source (i.e., kefir, certain yogurts, live culture, sauerkraut)
* Liver scan \>2 months prior to enrollment
* Weight loss \>5 pounds in the last 2 months
* Any implanted battery operated device (i.e. AICD, pacemaker, loop recorder, cochlear implant)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04175392
Study Brief:
Protocol Section:
NCT04175392