Effects of Probiotic on Inflammation and Microbiota in Patients With NASH

Stopped early · Phase 1/Phase 2

Conditions studied: Non-Alcoholic Fatty Liver Disease, Probiotics MeSH Descriptor Data 2018, Interleukin-17 MeSH Descriptor Data 2018

In brief

Individuals with clinically identified non-alcoholic fatty liver disease will undergo baseline evaluation of IL-17 and other inflammatory markers as well as microbiome determination. The probiotic formulation VSL#3 450 Billion CFU twice daily will be administered for 8 weeks and the determination of Il-17 and microbiome will be repeated. Each subject will serve as his or her own control.

Key facts

Study ID

NCT03511365

Run by

Northwell Health

People needed

6

Starts

2018-05-15

Expected to finish

2019-10-11

Last updated by the study team

2020-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Capable of giving informed consent
• Diagnosed with NAFLD as defined by the American Association for the Study of Liver Diseases (AASLD) who are treated or seen solely at the outpatient clinic at the Department of Hepatology at 400 Community Drive in Manhasset NY

You may not qualify if…

• Cirrhosis
• Absence of secondary causes of hepatic fat accumulation including:
• Excessive alcohol consumption
• Hepatitis C
• Wilson's Disease
• Lipodystrophy
• Starvation
• Parenteral Nutrition
• Abetalipoproteinemia
• Specific Medications: Amiodarone, Methotrexate, Tamoxifen, Corticosteroids, Valproate, Anti-retroviral agents)
• Reye's Syndrome
• HELLP Syndrome
• Inborn errors of metabolism (LCAT deficiency, cholesterol ester storage disease, Wolman disease)

Where it is running

• Northwell Health — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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