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NCT05635474
Effects of Bacillus Coagulans on Liver and Gut Microbiota Function in NAFLD
Conditions: Effects of Bacillus Coagulans TCI711 Supplementation on Liver and Gut Microbiota Function in Non-alcoholic Fatty Liver Disease Patients
Sex: All
Ages: 20 Years – 75 Years
Phase: NA
Enrollment: 60
Sponsor: Taipei Medical University
Location: Taiwan
Summary
According to the 2018 statistics of the American Association of Liver Diseases, about 25% of the world's population has non-alcoholic fatty liver disease, and about 10 to 20% of patients with simple fatty liver will develop non-alcoholic steatohepatitis, and about 25 to 50% of non-alcoholic fatty liver patients will continue to develop liver fibrosis, which may even lead to liver cirrhosis or liver cancer, so how to improve the liver fat accumulation of non-alcoholic fatty liver patients is one of the topics that scholars in related fields have paid attention to in recent years .
Bacillus coagulans is a Gram-positive bacterium belonging to the genus Bacillus and does not exist in the intestinal microbiota, because it has the characteristics of spore production and lactobacillus lactic acid production, and has the ability to maintain the health of intestinal bacteria, acid and alkali resistance, With the advantages of high temperature resistance and high stability, it is currently one of the commonly used probiotic strains.
Clinical studies have shown that after intervention of a single Bacillus coagulans strain in patients with non-alcoholic fatty liver disease, the problem of liver fat accumulation and inflammation can be significantly improved, so supplementing Bacillus coagulans TCI711 probiotics isolated from apples may improve Functions of liver and gut microbiota in patients with nonalcoholic fatty liver disease.
Therefore, this experiment is to investigate the effect of supplementing Bacillus coagulans TCI711 probiotics on the function of liver and intestinal flora in fatty liver patients.
Eligibility Criteria
Inclusion Criteria:20-75 years old adultHave fatty liver diseaseExclusion Criteria:History of hepatitis B, hepatitis C, cirrhosis, liver fibrosis, or bariatric surgeryControlled attenuation parameter for fatty liver degeneration < 220 dB/mHave taken antibiotics within 3 monthsHave participated in any trial or research project within 3 monthsTaking any nutritional supplements during the trialDiet without maintaining daily habits and avoiding alcohol intake
Source: ClinicalTrials.gov (NCT05635474). StuddyBuddy aggregates publicly available trial information.