Nutritional Counseling vs. Nutritional Supplements for NASH - a Randomized Prospective, Open Label Pilot Study (NucesNASH)

Johannes Gutenberg University (JGU)

Status and phase: Completed; Phase 2

Conditions: Fatty Liver, Nonalcoholic; Non-alcoholic Fatty Liver Disease

Treatments: Other: Nutritional Counseling and LCS; Behavioral: Nutritional Counseling; Dietary Supplement: Lactobacillus casei shirota (LCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02366052

SCHA 1015/5-1 (Other Grant/Funding Number)

NUCES_NASH-JGU

Details and patient eligibility

About

The main aim of the study is to determine if an oral supplementation of the LCS has a beneficial effect by itself or even enhances the beneficial effects of a moderate life-style intervention on the progression of NAFLD in humans.

Enrollment: 42 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elevated M30 antigen levels (cutoff: >200 - 800 U/L) at screening AND hepatic steatosis on ultrasound

OR histologically confirmed NASH

• Age 18 to 75 years

Exclusion criteria

• Alcohol intake of more than 30 g/d (men) or 20 g/d (women)
• Treatment with ursodeoxycholic acid (UDCA), Vitamin E or other investigational NASH drugs 3 months prior to randomization
• Treatment with medications or substances that may induce secondary NASH (e.g., tamoxifen, corticosteroids, amiodarone, methotrexate) or ameliorate NASH (TNF-antagonists)
• Treatment with phenprocoumon or warfarin
• Hepatocellular carcinoma or non-hepatic malignancy
• Decompensated cirrhosis (Child B,C) or a history of decompensation
• Liver disease unrelated to NASH, including chronic viral hepatitis B/D or C, autoimmune hepatitis, Wilson's disease or clinical manifest iron overload
• Bariatric surgery within the last 5 years
• BMI <18,5 kg/m2 or BMI >45 kg/m2
• Liver transplantation
• Heart failure (New York Heart Association Class II - IV)
• Myocardial infarction, instable coronary artery disease , coronary artery intervention or stroke in the previous 6 months
• Instable chronic obstructive pulmonary disease, chronic inflammatory bowel disease or rheumatoid arthritis.
• Instable renal insufficiency (changes in serum creatinin > 50% in the last 3 month) or terminal renal insufficiency requiring dialysis
• Uncontrolled hypertension (blood pressure > 180/90 despite therapy)
• Uncontrolled diabetes mellitus defined by hemoglobin A1c > 9
• Food allergies requiring strictly dietary adherence
• Pregnant or nursing women
• Chronic pancreatitis or history of recurring acute pancreatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Nutritional Counseling

Active Comparator group

Description:

The nutritional counseling group will receive dietary counseling focusing on a reduction of fructose intake by a trained nutritionist for 12 weeks every 3 weeks.

Treatment:

Behavioral: Nutritional Counseling

Nutritional Counseling and LCS

Experimental group

Description:

The dietary supplement LCS (Lactobacillus casei shirota ) will be given 2 times a day for 12 weeks in addition to the nutritional counseling every 3 weeks.

Treatment:

Other: Nutritional Counseling and LCS

Lactobacillus Casei Shirota

Experimental group

Description:

The dietary supplement LCS (Lactobacillus casei shirota ) will be given 2 times a day for 12 weeks.

Treatment:

Dietary Supplement: Lactobacillus casei shirota (LCS)