Randomized, Double-blind, Placebo-controlled Study of a Multispecies Probiotic Mixture in Nonalcoholic Fatty Liver Disease

Sang Bong Ahn, Dae Won Jun, Bo-Kyeong Kang, Jong Hyun Lim, Sanghyun Lim, Myung-Jun Chung, Sang Bong Ahn, Dae Won Jun, Bo-Kyeong Kang, Jong Hyun Lim, Sanghyun Lim, Myung-Jun Chung

Abstract

The intestinal microbiota is closely associated with the development of obesity and nonalcoholic fatty liver disease (NAFLD). This study investigated the effects of probiotic treatment on visceral fat area (VFA) and intrahepatic fat (IHF) fraction in NAFLD. Sixty-eight obese NAFLD patients (>5% proton density fat fraction [PDFF] on magnetic resonance imaging [MRI]) were randomized to probiotic and placebo groups for 12 weeks. The probiotic mixture included 6 bacterial species. VFA and IHF were measured using the MRI-PDFF technique. Body weight and total body fat were reduced in the probiotic group but not in the placebo group. The mean IHF fraction was reduced after 12 weeks of treatment in the probiotic group compared to that at baseline (from 16.3 ± 15.0% to 14.1 ± 7.7%, p = 0.032) but was not reduced in the placebo group. The decrease in IHF (mean difference: -2.61%, p = 0.012) was also greater in the probiotic group than in the placebo group. Reduction of triglyceride was greater in the probiotic treatment group than in the placebo group (mean difference: -34.0 mg/dl, p = 0.0033). However, the changes in IHF percentage and triglyceride levels were not different between placebo and control groups after adjusting for changes in body weight. Treatment with probiotics for 12 weeks resulted in significant reduction in IHF and body weight in obese NAFLD patients.

Conflict of interest statement

Jong Hyun Lim, Sanghyun Lim and Myung-Jun Chung are full-time employee of CELLBIOTECH. Sang Bong Ahn, Dae Won Jun and Bo-Kyeong Kang have nothing to disclose.

Figures

Figure 1
Figure 1
Consort flow chart.
Figure 2
Figure 2
Changes in weight and body fat according to treatment.
Figure 3
Figure 3
Changes in hepatic fat content in probiotic and placebo groups. (A) Individual patient data for hepatic fat content as assessed using MRI-PDFF at baseline and 12 weeks. The probiotic group had a significant reduction in hepatic fat after 12 weeks of treatment. (B) In the probiotic group, 40.0% showed a significant reduction in IHF, with no difference in 46.7% and worsening in 13.3%. In the control group, 17.1% showed a significant reduction in IHF, with no difference in 51.4% and worsening in 31.4%. More significant reduction in IHF was shown in the probiotic group than in the control group (40% vs. 17.1%, p = 0.038).

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