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

NCT05635474 | Unknown

• 1 other identifier: N202208021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Fibroscan

  Liver fibrometer (Echosens, Paris, France) can be quantified with specific numerical values, which can be used at the same time The degree of fatty liver and liver fibrosis can be detected in real time by measuring LSM and CAP by transient elastography (Shrestha et al., 2021). During the measurement, the patient is in a supine position, the right arm is abducted, the forearm is under the head, and the right side of the body is bare and slightly raised. The physician uses the ultrasound gel-covered probe tip to place in the intercostal space above the right liver lobe, and uses A mode Image localization of liver sections that are at least 6 cm thick and free of any large vascular structures, and the probe button is pressed for image acquisition, which measures in the depth range of 25-45 mm (Shrestha et al., 2021).

  two month

Study Arms (2)

dietary supplement

EXPERIMENTAL

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.

Dietary Supplement: Bacillus Coagulans

placebo

PLACEBO COMPARATOR

The placebo was also given in the form of capsules, the main ingredients were maltodextrin, silicon dioxide and magnesium stearate

Dietary Supplement: Placebo

Interventions

Bacillus Coagulans DIETARY_SUPPLEMENT

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.

dietary supplement

Placebo DIETARY_SUPPLEMENT

The placebo was also administered in the form of capsules consisting of maltodextrin, silicon dioxide, and magnesium stearate.

placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old adult
• Have fatty liver disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead
• TCI Co., Ltd.: collaborator

Study Sites (1)

Taipei Medical university

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Interventions

exopolysaccharide biopolymer, Bacillus coagulans

Central Study Contacts

Yung Ming-Ta, Doctor

CONTACT

02-27361661; yangrugby@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: September 25, 2022
• Primary Completion: December 5, 2022
• Study Completion: May 31, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-11

Locations

TW (1)