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

NCT05402449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-07-05

No results posted yet for this study

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

Interventions

OTHER

Placebo

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

DIETARY_SUPPLEMENT

Probiotics

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

Sponsors & Collaborators

  • Fu Jen Catholic University Hospital

    collaborator OTHER

  • GenMont Biotech Incorporation

    lead INDUSTRY

Principal Investigators

  • Chi-Yang Chang, PhD · Fu Jen Catholic University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-14
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05402449 on ClinicalTrials.gov