Evaluate the Effect of Synbiotics on MAFLD

NCT06537882 | Active Not Recruiting

• 1 other identifier: MAFLD-RCT
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. Available data indicates that probiotics may regulate the gut microbiota, while Vitamin E and omega 3 are safe and effective at treating NAFLD patients. In this study, investigators aim to investigate if the enhanced synbiotic preparation of SLP07 is efficacious in liver function improvement in subjects with MAFLD.

Conditions

Metabolic Dysfunction-Associated Fatty Liver Disease

Keywords

Metabolic dysfunction-Associated Fatty Liver Disease; Synbiotics

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with a reduction of at least 1 grade of steatosis AND/OR >10% reduction in CAP scores at 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 (8)

• Percentage of participants with improvement in steatohepatitis across the study period.

  3 months

• Change in lipid profile 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

• Adverse events reported during the study period.

  3 months

Study Arms (2)

Active arm

ACTIVE COMPARATOR

Subjects will take 1 sachet of G-NiiB synbiotics formula (SLP07) daily for 3 months

Dietary Supplement: G-NiiB synbiotics formula (SLP07)

Placebo arm

PLACEBO COMPARATOR

Subjects will take 1 sachet of active vitamin daily for 3 months

Dietary Supplement: Active placebo

Interventions

G-NiiB synbiotics formula (SLP07) DIETARY_SUPPLEMENT

SLP07 consists of a blend of food-grade Bifidobacterium and Lactobacillus as active probiotics, omega 3, and vitamin E.

Active arm

Active placebo DIETARY_SUPPLEMENT

Active placebo contains 2mg of vitamin C with corn starch filler

Placebo arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with MAFLD with CAP ≥ 270 by fibroscan
• Age ≥ 50
• Subjects with diabetes or components of metabolic syndrome
• Subjects have been taking stable medication 3 months prior to enrolment and are expected to remain stable throughout the study period
• Written informed consent can be obtained

You may not qualify if:

• Known history of any secondary causes of MAFLD including alcoholic liver disease, drug-induced liver injury, autoimmune hepatitis, viral hepatitis, cholestatic liver disease and metabolic/genetic liver disease
• Active malignancy (on any kind of treatments for the known cancer)
• 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 wine glass)
• Subjects who are using insulin and Glucagon-like peptide-1(GLP1) such as dulaglutide, semaglutide
• Consumption of systemic corticosteroids or methotrexate in the last 6 months
• Use of antibiotics, probiotics or prebiotics one month prior to enrolment
• Taking any supplements which are claimed to possibly protect the liver or improve liver functions including vitamin E and omega-3
• Any condition or allergy history for probiotics
• Any allergy to vitamin E, omega-3 or lactose

Sponsors & Collaborators

• GenieBiome Limited: lead
• Microbiota I-Centre (MagIC): collaborator

Study Sites (1)

GenieBiome Limited

Hong Kong, Hong Kong

Location

Related Publications (16)

• Wong VW, Chu WC, Wong GL, Chan RS, Chim AM, Ong A, Yeung DK, Yiu KK, Chu SH, Woo J, Chan FK, Chan HL. Prevalence of non-alcoholic fatty liver disease and advanced fibrosis in Hong Kong Chinese: a population study using proton-magnetic resonance spectroscopy and transient elastography. Gut. 2012 Mar;61(3):409-15. doi: 10.1136/gutjnl-2011-300342. Epub 2011 Aug 16.

  PMID: 21846782 BACKGROUND

• Bellentani S, Scaglioni F, Marino M, Bedogni G. Epidemiology of non-alcoholic fatty liver disease. Dig Dis. 2010;28(1):155-61. doi: 10.1159/000282080. Epub 2010 May 7.

  PMID: 20460905 BACKGROUND

• Amarapurkar DN, Hashimoto E, Lesmana LA, Sollano JD, Chen PJ, Goh KL; Asia-Pacific Working Party on NAFLD. How common is non-alcoholic fatty liver disease in the Asia-Pacific region and are there local differences? J Gastroenterol Hepatol. 2007 Jun;22(6):788-93. doi: 10.1111/j.1440-1746.2007.05042.x.

  PMID: 17565631 BACKGROUND

• Chitturi S, Wong VW, Farrell G. Nonalcoholic fatty liver in Asia: Firmly entrenched and rapidly gaining ground. J Gastroenterol Hepatol. 2011 Jan;26 Suppl 1:163-72. doi: 10.1111/j.1440-1746.2010.06548.x.

  PMID: 21199528 BACKGROUND

• Caldwell SH, Oelsner DH, Iezzoni JC, Hespenheide EE, Battle EH, Driscoll CJ. Cryptogenic cirrhosis: clinical characterization and risk factors for underlying disease. Hepatology. 1999 Mar;29(3):664-9. doi: 10.1002/hep.510290347.

  PMID: 10051466 BACKGROUND

• Farrell GC, Larter CZ. Nonalcoholic fatty liver disease: from steatosis to cirrhosis. Hepatology. 2006 Feb;43(2 Suppl 1):S99-S112. doi: 10.1002/hep.20973.

  PMID: 16447287 BACKGROUND

• Hamaguchi M, Kojima T, Takeda N, Nagata C, Takeda J, Sarui H, Kawahito Y, Yoshida N, Suetsugu A, Kato T, Okuda J, Ida K, Yoshikawa T. Nonalcoholic fatty liver disease is a novel predictor of cardiovascular disease. World J Gastroenterol. 2007 Mar 14;13(10):1579-84. doi: 10.3748/wjg.v13.i10.1579.

  PMID: 17461452 BACKGROUND

• Wong VW, Wong GL, Yip GW, Lo AO, Limquiaco J, Chu WC, Chim AM, Yu CM, Yu J, Chan FK, Sung JJ, Chan HL. Coronary artery disease and cardiovascular outcomes in patients with non-alcoholic fatty liver disease. Gut. 2011 Dec;60(12):1721-7. doi: 10.1136/gut.2011.242016. Epub 2011 May 20.

  PMID: 21602530 BACKGROUND

• Eslam M, Sanyal AJ, George J; International Consensus Panel. MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology. 2020 May;158(7):1999-2014.e1. doi: 10.1053/j.gastro.2019.11.312. Epub 2020 Feb 8.

  PMID: 32044314 BACKGROUND

• Loguercio C, De Simone T, Federico A, Terracciano F, Tuccillo C, Di Chicco M, Carteni M. Gut-liver axis: a new point of attack to treat chronic liver damage? Am J Gastroenterol. 2002 Aug;97(8):2144-6. doi: 10.1111/j.1572-0241.2002.05942.x. No abstract available.

  PMID: 12190198 BACKGROUND

• Solga SF, Diehl AM. Non-alcoholic fatty liver disease: lumen-liver interactions and possible role for probiotics. J Hepatol. 2003 May;38(5):681-7. doi: 10.1016/s0168-8278(03)00097-7. No abstract available.

  PMID: 12713883 BACKGROUND

• Eslamparast T, Eghtesad S, Hekmatdoost A, Poustchi H. Probiotics and Nonalcoholic Fatty liver Disease. Middle East J Dig Dis. 2013 Jul;5(3):129-36.

  PMID: 24829682 BACKGROUND

• Pandey KR, Naik SR, Vakil BV. Probiotics, prebiotics and synbiotics- a review. J Food Sci Technol. 2015 Dec;52(12):7577-87. doi: 10.1007/s13197-015-1921-1. Epub 2015 Jul 22.

  PMID: 26604335 BACKGROUND

• Yadav MK, Kumari I, Singh B, Sharma KK, Tiwari SK. Probiotics, prebiotics and synbiotics: Safe options for next-generation therapeutics. Appl Microbiol Biotechnol. 2022 Jan;106(2):505-521. doi: 10.1007/s00253-021-11646-8. Epub 2022 Jan 11.

  PMID: 35015145 BACKGROUND

• Jump DB, Lytle KA, Depner CM, Tripathy S. Omega-3 polyunsaturated fatty acids as a treatment strategy for nonalcoholic fatty liver disease. Pharmacol Ther. 2018 Jan;181:108-125. doi: 10.1016/j.pharmthera.2017.07.007. Epub 2017 Jul 16.

  PMID: 28723414 BACKGROUND

• Spooner MH, Jump DB. Omega-3 fatty acids and nonalcoholic fatty liver disease in adults and children: where do we stand? Curr Opin Clin Nutr Metab Care. 2019 Mar;22(2):103-110. doi: 10.1097/MCO.0000000000000539.

  PMID: 30601174 BACKGROUND

Study Officials

• Jessica Ching, PhD

  GenieBiome Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Attending physicians, investigators performing assessments in clinic visits and study participants will be blinded to the group allocation until study completion.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will be randomized into two groups to take SLP07 or placebo daily for 3 months with monthly assessment.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 5, 2024
• Study Start: May 17, 2024
• Primary Completion: February 7, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)