A Clinical Study to Evaluate the Effect of SIM01 in Female With NAFLD

NCT05885373 | Completed

• 1 other identifier: GB-NAFLD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Non-alcoholic fatty liver disease is one of the most common chronic liver diseases worldwide. Available data indicates that probiotics may regulate the gut microbiota and improve liver function in females with non-alcoholic fatty liver disease. In this study, we aim to investigate if the synbiotics (prebiotics and probiotics) are efficacious subjects in liver function improvement in female subjects with Non-alcoholic fatty liver disease.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Non-Alcoholic Fatty Liver Disease; Probiotics

Outcome Measures

Primary Outcomes (1)

• Change in Controlled Attenuation Parameter (CAP) score by fibroscan after taking SIM01 for 3 months

  The change of CAP score measured by fibroscan. CAP score is a measurement of fat accumulation in the liver to further determine the steatosis grade. The CAP score ranges from 100 to 400 decibels per meter (dB/m). The higher the score, the more the steatosis is.

  3 months

Secondary Outcomes (5)

• Change in liver enzymes (alanine aminotransferase (ALT) and aspartate transaminase (AST)) across the study period.

  3 months

• Change in fasting lipid and HbA1c across the study period.

  3 months

• Change of body mass index (BMI) across the study period.

  3 months

• Change of body waist circumference across the study period.

  3 months

• Change in interleukin-6 (IL-6) across the study period.

  3 months

Study Arms (1)

SIM01

EXPERIMENTAL

2 sachets daily for 3 months

Dietary Supplement: SIM01

Interventions

SIM01 DIETARY_SUPPLEMENT

SIM01 consists of a blend of food-grade Bifidobacterium as active probiotics

Also known as: G-NiiB Immunity formula

SIM01

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects with NAFLD with CAP ≥ 270 by fibroscan
• Age ≥ 55
• Subjects with or without diabetes or components of metabolic syndrome and having stable medication 3 months prior to enrolment
• Written informed consent can be obtained

You may not qualify if:

• Known history of any secondary causes of NAFLD including alcoholic liver disease, drug-induced liver injury, autoimmune hepatitis, viral hepatitis, cholestatic liver disease and metabolic/genetic liver disease
• Known diabetes with poor control (HbA1c \> 8.5%) within 3 months
• Significant alcohol consumption (over 10g per day: a half pint or half bottle of beer or a standard-size of a wine glass)
• Consumption of systemic corticosteroids or methotrexate in the last 6 months
• Concomitant probiotics or prebiotics one month prior to enrolment
• Any condition or allergy history for probiotics
• Subjects who are using antibiotics, insulin and Glucagon-like peptide-1(GLP1) such as dulaglutide, semaglutide
• Malignancy

Sponsors & Collaborators

• GenieBiome Limited: lead

Study Sites (1)

GenieBiome Limited

Hong Kong, Hong Kong

Location

Related Publications (28)

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MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Jessica Ching, PhD

  GenieBiome Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All study subjects will receive the same study products.

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: June 1, 2023
• Study Start: March 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)