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

NCT04074889 | Unknown

• 1 other identifier: FRGS/1/2018/SKK02/UKM/03/2
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Probiotics; Gut Liver Axis

Outcome Measures

Primary Outcomes (1)

• Mean difference in hepatic steatosis score

  as measured by Controlled Attenuated Parameter score from Transient Elastography (Fibroscan)

  6-7 months post supplementation

Secondary Outcomes (5)

• Mean difference in hepatic fibrosis score

  6-7 months post supplementation

• Mean difference in hepatic steatosis, inflammation and fibrosis scores

  6-7 months post supplementation

• Microbiota composition of small intestine

  6-7 months post supplementation

• Mean difference of immunoreactivity score of zona occludens-1 (ZO-1: indicator of intestinal permeability) and CD4+,CD8+, IL-8 (indicator of intestinal mucosal immune system).

  6-7 months post supplementation

• Mean difference in mRNA expression of genes related to inflammation (IL-6, TNF-alpha, IFN-gamma)

  6-7 months post supplementation

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients will be given Lactobacillus \& Bifidobacterium containing probiotics \[Lactobacillus acidophilus (107mg), Lactobacillus casei subsp (107mg), Lactobacillus lactis (107mg), Bifidobacterium bifidum (107mg), Bifidobacterium infantis (107mg) and Bifidobacterium longum (107mg\], to be taken 1 sachet twice daily for 6 months.

Dietary Supplement: (Microbial cell preparation) Probiotics

Group B

PLACEBO COMPARATOR

Patients will be given placebo sachet (exactly the same packaging as active comparator) to be taken 1 sachet twice daily for 6 months.

Other: Placebo

Interventions

(Microbial cell preparation) Probiotics DIETARY_SUPPLEMENT

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

Also known as: Hexbio

Group A

Placebo OTHER

Placebo sachet with no microbial cell preparation

Group B

Eligibility Criteria

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

You may qualify if:

• Age 18 and above 2. Diagnosis of NAFLD is confirmed by the presence of fatty liver detected by abdominal ultrasound and controlled attenuation parameter (CAP) score from FibroScan® of \>263 3. Raised ALT level (above upper limit of normal): \> 35IU/L for males and \> 25 IU/L for females

You may not qualify if:

• Evidence of other chronic liver diseases (as determined by clinical and standard investigations) - e.g. Hepatitis B, C infections, autoimmune hepatic disorders.
• Evidence of acute disorders that affecting the liver - e.g. drug induced liver injury, non-Hepatitis B, C viral infection.
• Biliary disease.
• Liver cancer - primary hepatocellular carcinoma or liver metastasis.
• Evidence of liver cirrhosis.
• Alcohol intake \> 20g/day for males and \>10g/day for females.
• Use of steatogenic medications within the past one months - e.g. systemic steroids, methotrexate.
• History of bariatric surgery
• Intake of antibiotics and/or probiotic and proton pump inhibitor within one month before the start of the study or during the study period.

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead
• B-Crobes Laboratory Sdn. Bhd: collaborator
• Fibronostics Pte. Ltd: collaborator
• Ministry of Education, Malaysia: collaborator

Study Sites (1)

The University of Malaysia Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Khairul Najmi Muhammad Nawawi, MBBCh BAO

  The University of Malaysia Medical Centre, Kuala Lumpur, Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khairul Najmi Muhammad Nawawi, MBBCh BAO

CONTACT

+60183734807; khairulnajmi84@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: August 30, 2019
• Study Start: August 30, 2019
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 4, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)