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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Bacillus Coagulans
Placebo
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Effects of Bacillus Coagulans TCI711 Supplementation on Liver and Gut Microbiota Function in Non-alcoholic Fatty Liver Disease Patients

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Taipei Medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dietary supplement

placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 22, 2022
Last Updated
November 22, 2022
Sponsor
Taipei Medical University
Collaborators
TCI Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05635474
Brief Title
Effects of Bacillus Coagulans on Liver and Gut Microbiota Function in NAFLD
Official Title
Effects of Bacillus Coagulans TCI711 Supplementation on Liver and Gut Microbiota Function in Non-alcoholic Fatty Liver Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2022 (Actual)
Primary Completion Date
December 5, 2022 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University
Collaborators
TCI Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effects of Bacillus Coagulans TCI711 Supplementation on Liver and Gut Microbiota Function in Non-alcoholic Fatty Liver Disease Patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dietary supplement
Arm Type
Experimental
Arm 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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The placebo was also given in the form of capsules, the main ingredients were maltodextrin, silicon dioxide and magnesium stearate
Intervention Type
Dietary Supplement
Intervention Name(s)
Bacillus Coagulans
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The placebo was also administered in the form of capsules consisting of maltodextrin, silicon dioxide, and magnesium stearate.
Primary Outcome Measure Information:
Title
Fibroscan
Description
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).
Time Frame
two month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yung Ming-Ta, Doctor
Phone
02-27361661
Ext
2275
Email
yangrugby@tmu.edu.tw
Facility Information:
Facility Name
Taipei Medical university
City
Taipei city
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yung Ming-Ta, Doctor
Phone
27361661
Ext
2275
Email
yangrugby@tmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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