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

Journal: Clinical nutrition ESPEN 2021;39():53-60

PMID: 32859329

Full Text on Elsevier Science View on PubMed

Abstract

BACKGROUND

The aim of this study was to evaluate the effects of supplementation with 10 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.

Address: 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.; 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.; Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.; Amol Faculty of Paramedical Sciences, Mazandaran University of Medical Sciences, Sari, Iran.; Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran.; 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: [email protected].

DOI: 10.1016/j.clnesp.2020.06.020

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MeSH Terms: Alanine Transaminase, Bacillus coagulans, Humans, Inflammation, Non-alcoholic Fatty Liver Disease, Synbiotics