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Effects of Bacillus Coagulans on Liver and Gut Microbiota Function in NAFLD

T

Taipei Medical University

Status

Enrolling

Conditions

Effects of Bacillus Coagulans TCI711 Supplementation on Liver and Gut Microbiota Function in Non-alcoholic Fatty Liver Disease Patients

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Bacillus Coagulans

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05635474
N202208021

Details and patient eligibility

About

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.

Full description

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.

All the participants in the experiment were subjected to body position measurement, blood and feces collection, liver fiber analyzer analysis and questionnaire survey before supplementation. Afterwards, the subjects were divided into the experimental group and the placebo group in a random and double-blind manner. The experimental group was given Participants ingested one capsule containing the Bacillus coagulans TCI711 probiotic daily for 8 weeks, while the placebo group received a placebo-only capsule. All participants in the experiment took body position measurement and questionnaire survey again 4 weeks after supplementation, and body position measurement, blood and feces collection, liver fiber analyzer analysis and questionnaire survey again 12 weeks after supplementation. Blood was collected once each time, and 24 mL of blood was collected each time, and a total of 48 mL of blood was collected to evaluate the benefit of supplementing Bacillus coagulans TCI711 probiotics.

Bacillus coagulans TCI711 probiotics are expected to be beneficial to liver and intestinal flora functions in patients with fatty liver disease.

Enrollment

60 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 20-75 years old adult
  • Have fatty liver disease

Exclusion criteria

  • History of hepatitis B, hepatitis C, cirrhosis, liver fibrosis, or bariatric surgery
  • Controlled attenuation parameter for fatty liver degeneration < 220 dB/m
  • Have taken antibiotics within 3 months
  • Have participated in any trial or research project within 3 months
  • Taking any nutritional supplements during the trial
  • Diet without maintaining daily habits and avoiding alcohol intake

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

dietary supplement
Experimental group
Description:
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. Bacillus coagulans does not exist in intestinal microbiota, because it has 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.
Treatment:
Dietary Supplement: Bacillus Coagulans
placebo
Placebo Comparator group
Description:
The placebo was also given in the form of capsules, the main ingredients were maltodextrin, silicon dioxide and magnesium stearate
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Central trial contact

Yung Ming-Ta, Doctor

Data sourced from clinicaltrials.gov

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