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The Effect of Probiotics on the Clinical Outcomes and Gut Microenvironment in Patients With Fatty Liver

NCT04074889 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-09-04

No results posted yet for this study

Summary

Fatty liver has been associated with high risk of progression to inflammation of the liver, liver cirrhosis (hardening of the liver), and eventually can lead to liver cancer. So far, the treatment for this condition involves controlling the cholesterol level in the body by practicing low fat diet and daily exercise. However, recently there has been evidence that alteration of the normal population of various types of bacteria that lives in the intestines may contributes to the development of fatty liver.

Probiotics is a dietary supplement containing live bacteria that is formulated to change the composition and population of the bacteria in the intestines. It is postulated that by taking specifically formulated probiotics, the alteration of the intestinal bacteria may lead to improvement of the fatty liver, leading to better daily liver function.

In this 6-month study, investigators would like to investigate the effectiveness of the probiotics in improving the liver function and in the treatment of the fatty liver. It will compare the fatty liver of patients who took the probiotics supplements compared to those who did not took it and see if there is any improvement.

Conditions

  • Non-Alcoholic Fatty Liver Disease

Interventions

DIETARY_SUPPLEMENT

(Microbial cell preparation) Probiotics

Lactobacillus acidophilus (107mg), Lactobacillus casei subsp (107mg), Lactobacillus lactis (107mg), Bifidobacterium bifidum (107mg), Bifidobacterium infantis (107mg) and Bifidobacterium longum (107mg)

OTHER

Placebo

Placebo sachet with no microbial cell preparation

Sponsors & Collaborators

  • B-Crobes Laboratory Sdn. Bhd

    collaborator UNKNOWN

  • Fibronostics Pte. Ltd

    collaborator UNKNOWN

  • Ministry of Education, Malaysia

    collaborator OTHER_GOV

  • Universiti Kebangsaan Malaysia Medical Centre

    lead OTHER

Principal Investigators

  • Khairul Najmi Muhammad Nawawi, MBBCh BAO · The University of Malaysia Medical Centre, Kuala Lumpur, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-30
Primary Completion
2020-07-31
Completion
2020-12-31

Countries

  • Malaysia

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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 NCT04074889 on ClinicalTrials.gov