Effect of Probiotics in Non-alcoholic Fatty Liver Disease and Steatohepatitis

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effect of probiotics, a beneficial intestinal bacteria supplement, if it will cause improvement of the non-alcoholic fatty liver disease (NAFLD) and or non-alcoholic steatohepatitis (NASH- an inflammation with concurrent fatty accumulation of the liver) as measured by transient elastography - an ultrasound of the liver that assess the elastic properties (density) and stiffness of the liver tissue. This study will enroll patients 18 years and older with diagnosis of NAFLD and or NASH.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Beaumont Hospitals

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)