Effect of Probiotics in the Treatment of Nonalcoholic Fatty Liver Disease

Design The study is a single-center double blind, placebo controlled, parallel group study. Patients were randomized to receive either the probiotic supplement (1.109 Lactobacillus acidophilus ATCC SD5221 and 1.109 Bifidobacterium lactis HN019) or placebo for 6 months. All participants receive individualized dietary couseling sessions with a nutritionist.

Randomization Randomization was performed using the website www.randomization.com. The allocation sequence remained concealed throughout the study. Researchers, outcome assessors and patients were blinded to the treatment received.

The trial was registered at www.clinicaltrials.gov. (number NCT02764047)

Intervention Patients receive the probiotic or placebo supplement in identical medicine bottles to maintain blinding. The instruction for administration of the capsules is taking 1 capsule per day before bedtime with 1 cup of water. Patients are also advised to keep medications in use without change until the end of the study and to communicate the investigators if they used antibiotics.

Questionary - Profile and the risk factors for fibrosis and NASH The profile of patients with NASH will be analyzed according to the variables collected (age, gender, smoking, diabetes, hypertension, high blood pressure, heart rate, weight, height, BMI, waist circumference, AST, ALT, total bilirubin, albumin, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, glucose, insulin, C-reactive protein, platelets), as well as the possible risk factors for the development of the disease. It is believed that the interaction between diet, intestinal microbiota and genetic background is the most important in the development and progression of NAFLD.