The effects of Bacillus coagulans supplementation in patients with non-alcoholic fatty liver disease: A randomized, placebo-controlled, clinical trial

Khadijeh Abhari; Saeede Saadati; Zahra Yari; Hedayat Hosseini; Mehdi Hedayati; Shahabeddin Abhari; Seyyed Moayyed Alavian; Azita Hekmatdoost

doi:10.1016/j.clnesp.2020.06.020

The effects of Bacillus coagulans supplementation in patients with non-alcoholic fatty liver disease: A randomized, placebo-controlled, clinical trial

Clin Nutr ESPEN. 2020 Oct:39:53-60. doi: 10.1016/j.clnesp.2020.06.020. Epub 2020 Jul 24.

Authors

Khadijeh Abhari¹, Saeede Saadati¹, Zahra Yari¹, Hedayat Hosseini², Mehdi Hedayati³, Shahabeddin Abhari⁴, Seyyed Moayyed Alavian⁵, Azita Hekmatdoost⁶

Affiliations

¹ Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
² Department of Food Technology, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
³ Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
⁴ Amol Faculty of Paramedical Sciences, Mazandaran University of Medical Sciences, Sari, Iran.
⁵ Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran.
⁶ Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: a_hekmat2000@yahoo.com.

PMID: 32859329
DOI: 10.1016/j.clnesp.2020.06.020

Abstract

Background: The aim of this study was to evaluate the effects of supplementation with 10⁹ spores of Bacillus coagulans (GBI-30) plus inulin in patients with non-alcoholic fatty liver disease (NAFLD).

Methods: In a randomized, double-blind, placebo-controlled clinical trial, fifty three patients with NAFLD were randomly assigned to receive either a synbiotic or a placebo capsule for 12 weeks. The primary outcome was reduction in steatosis score in Fibroscan exam.

Results: At the end of study, serum alanine aminotransferase and γ glutamine transaminase decreased significantly more in synbiotic group compared to placebo group (p = 0.001, and p = 0.004, respectively). Synbiotic supplementation significantly reduced serum tumor necrosis factor-α (p = 0.03) and nuclear factor-κB activity (p = 0.04). Moreover, hepatic steatosis reduced significantly more in synbiotic group compared to placebo group (p < 0.001).

Conclusion: Our results indicate that 12 weeks supplementation with B. coagulans plus inulin is beneficial for treatment of NAFLD and its related inflammation without any significant effects on related cardiovascular risk factors.

Clinical trials: This trial was registered at irct.ir with number of IRCT20100524004010N23.

Keywords: Bacillus coagulans; Clinical trial; Fatty liver; Probiotics.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Alanine Transaminase
Bacillus coagulans*
Humans
Inflammation
Non-alcoholic Fatty Liver Disease* / drug therapy
Synbiotics*

Substances

Alanine Transaminase