NCT05635474

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

Status unknown NA Last updated 2 December 2022

What this trial tests

NA trial testing Bacillus Coagulans in Effects of Bacillus Coagulans TCI711 Supplementation on Liver and Gut Microbiota Function in Non-alcoholic Fatty Liver Disease Patients in 60 participants. Status unknown.

Timeline

25 September 2022

Primary endpoint
5 December 2022

31 May 2023

Quick facts

Lead sponsor	Taipei Medical University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	supportive care
Enrollment	60
Start date	25 September 2022
Primary completion	5 December 2022
Estimated completion	31 May 2023
Sites	1 location across Taiwan

Drugs / interventions tested

• Bacillus Coagulans — full drug profile →
• Placebo

Conditions studied

• Effects of Bacillus Coagulans TCI711 Supplementation on Liver and Gut Microbiota Function in Non-alcoholic Fatty Liver Disease Patients — all drugs for Effects of Bacillus Coagulans TCI711 Supplementation on Liver and Gut Microbiota Function in Non-alcoholic Fatty Liver Disease Patients →

Sponsor

Taipei Medical University

Who can join

Adults 20 to 75, any sex, with Effects of Bacillus Coagulans TCI711 Supplementation on Liver and Gut Microbiota Function in Non-alcoholic Fatty Liver Disease Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Non-alcoholic fatty liver disease: Immunological mechanisms and current treatments.
   Petagine L, Zariwala MG, Patel VB. · · 2023 · cited 27× · PMID 37701135 · DOI 10.3748/wjg.v29.i32.4831
2. Targeting the Adipose Tissue-Liver-Gut Microbiota Crosstalk to Cure MASLD.
   Gabbia D, De Martin S. · · 2023 · cited 10× · PMID 38132297 · DOI 10.3390/biology12121471
3. <i>Bacillus coagulans</i> TCI711 Supplementation Improved Nonalcoholic Fatty Liver by Modulating Gut Microbiota: A Randomized, Placebo-Controlled, Clinical Trial.
   Hsieh RH, Chien YJ, Lan WY, Lin YK, et al · · 2024 · cited 9× · PMID 38510931 · DOI 10.1016/j.cdnut.2024.102083
4. Nutritional Interventions with <i>Bacillus coagulans</i> Improved Glucose Metabolism and Hyperinsulinemia in Mice with Acute Intermittent Porphyria.
   Longo M, Jericó D, Córdoba KM, Riezu-Boj JI, et al · · 2023 · cited 3× · PMID 37569315 · DOI 10.3390/ijms241511938