Non-Alcoholic Fatty Liver Disease Clinical Trial
— NASHOfficial title:
Effect of Probiotic Supplementation in Nonalcoholic Steatohepatitis Patients: Randomized Clinical Trial - PROBILIVER TRIAL
Verified date | June 2020 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Non-alcoholic Fatty Liver Disease (NAFLD) is characterized by excessive accumulation of
lipids in hepatocytes, not associated with alcohol consumption and ranges from hepatic
steatosis to steatohepatitis, a form that can progress to cirrhosis or hepatocarcinoma, and
is considered a liver manifestation of the metabolic syndrome (MetS). The disease occurs in
16 - 30% of the general population, but can reach up to 90% of obese individuals. Changes in
lifestyle, including weight loss and physical activity are indicated with first choices for
improvement of the liver condition.
Recently the relationship between obesity, diabetes, MetS and NAFLD with intestinal
microbiota has also been suggested in the development and progression of liver disease, since
it is related to hepatic steatosis and inflammation. In this sense, this work aims to
evaluate the effects of probiotic supplementation on intestinal microbiota modulation, degree
of hepatic fibrosis and steatosis, inflammation and body composition.
Status | Active, not recruiting |
Enrollment | 46 |
Est. completion date | December 20, 2021 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - adult outpatient with diagnostic of NAFLD Exclusion Criteria: - HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infected patients - significant intake of alcohol - cirrhosis, - pregnant women, - transplanted patients, - intake of supplements or foods containing probiotics, - immunosuppressants, antibiotics, corticosteroids, valproic acid and amiodarone, - other chronic inflammatory diseases |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clinicas de Porto Alegre | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hepatic fibrosis | change in the degree of fibrosis by hepatic elastography and scores | 24 weeks | |
Primary | cardiovascular risk | change in scores and sistemic markers | 24 weeks | |
Secondary | diversity of gut microbiota | by metagenomics from faecal samples | 24 weeks | |
Secondary | inflammation by TLR4 expression | by ELISA | 24 weeks | |
Secondary | inflammation by CK18 expression | by ELISA | 24 weeks | |
Secondary | inflammation by serum C-reactive protein | by nephelometry | 24 weeks | |
Secondary | metabolic syndrome | reduce in number of metabolic syndrome components | 24 weeks | |
Secondary | change in body composition by DEXA | densitometer GE Medical Systems Lunar Prodigy | 24 weeks | |
Secondary | body composition by bioimpedance | by change in phase angle | 24 weeks | |
Secondary | change in hand grip strength | by manual dynamometry | 24 weeks | |
Secondary | change in physical ability | by walk speed test | 24 weeks | |
Secondary | change in the parameters of sarcopenia by serum myostatin | by ELISA | 24 weeks | |
Secondary | change in the parameters of sarcopenia by serum testosterone | by electrochemiluminescence | 24 weeks |
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