To Evaluate the Beneficial Effect of Probiotics on NAFLD Patients and the Role of Gut Microbiota Modulation

NCT05402449 | Completed

• 1 other identifier: NAFLD2022
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the improvement of the clinical status of early-stage non-alcoholic fatty liver disease (NAFLD) patients after the probiotic intervention will be assessed. And the mechanism of probiotics to prevent the progression of illness would be investigated. The chronic inflammation status, systemic oxidative stress, metabolism of carbohydrates and lipid, and gut microbiota of NAFLD patients will also be analyzed.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Probiotic; Non-Alcoholic Fatty Liver Disease; gut microbiota

Outcome Measures

Primary Outcomes (3)

• Serum ALT (Alanine Aminotransferase) level at baseline

  The number of patients will be enrolled with the concentration of ALT (Alanine Aminotransferase) ranging from 60 to 300 U/mL in serum.

  baseline

• Change from baseline in Serum ALT (Alanine Aminotransferase) level at 3-months

  Fasting blood samples will be collected to examine the variation of ALT (Alanine Aminotransferase).

  3-months

• Change from baseline in Serum ALT (Alanine Aminotransferase) level at 6-months

  Fasting blood samples will be collected to examine the variation of ALT (Alanine Aminotransferase).

  6-months

Secondary Outcomes (51)

• Change from baseline in BMI (Body Mass index) at 3-months

  3-months

• Change from baseline in BMI (Body Mass index) at 6-months

  6-months

• Change from baseline in Waist and hip circumference at 3-months

  3-months

• Change from baseline in Waist and hip circumference at 6-months

  6-months

• Change from baseline in blood pressure at 3-months

  3-months

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Subjects received two placebo sachets per day

Other: Placebo

Probiotic group

EXPERIMENTAL

Subjects received two probiotic sachets per day

Dietary Supplement: Probiotics

Interventions

Placebo OTHER

Same Additives to Probiotic group but replace probiotics with Corn starch and Maltodextrin.

Also known as: Control group

Placebo group

Probiotics DIETARY_SUPPLEMENT

Multi-strain probiotic supplement includes Lactobacillus reuteri GMNL-263 (heat-killed) and GMNL-89 (alive) and Lactobacillus rhamnosus GMNL-74 ( alive).

Also known as: Test group

Probiotic group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Nonalcoholic fatty liver disease (NALFD) by ultrasound.
• The range of Alanine aminotransferase (ALT) blood test is 60-300 U/L

You may not qualify if:

• Alcoholic consumption (Female ≥ 10g/day or Male ≥ 20g/per)
• Patients with liver diseases, HBV(hepatitis B virus), HCV(hepatitis C virus), Primary Biliary Cholangitis.
• Autoimmune system disease
• Wilson's disease
• Hereditary hemochromatosis
• Patients with uncontrolled malignancy
• The subject had previously received weight reduction surgery
• Taking Antibiotics, probiotics, or any other drugs that affect NAFLD or glucose and lipid metabolism in past 2 months
• Pregnant or lactating female patients
• Patient who have severe allergy to soybeans or peanuts

Sponsors & Collaborators

• GenMont Biotech Incorporation: lead
• Fu Jen Catholic University Hospital: collaborator

Study Sites (1)

Fu Jen Catholic University Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Control Groups; Probiotics

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Chi-Yang Chang, PhD

  Fu Jen Catholic University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trail

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: June 2, 2022
• Study Start: July 14, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: July 5, 2024

Record last verified: 2023-09

Locations

TW (1)