Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
54 participants
INTERVENTIONAL
2024-05-17
2026-06-30
Brief Summary
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Detailed Description
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Recently, it has been reported that NAFLD might be linked to small intestinal bacterial overgrowth (SIBO), which induces liver injury by gut-derived lipopolysaccharides (LPS) and TNF- α production. (10) Probiotics have several anti-inflammatory effects that can contribute to their clinical benefits in NAFLD.(11) Gut microbiota also plays a role in the development of insulin resistance, hepatic steatosis, necroinflammation and fibrosis. (12) The use of probiotics, prebiotics and synbiotics has been considered a potential and promising strategy to regulate the gut microbiota.(13,14) In the meantime, Vitamin E has been recommended for use in NAFLD treatmentand prevents liver injury. Moreover, many clinical trials and meta-analyses have evaluated the efficacy of omega 3 (C20-22 ω3 polyunsaturated fatty acids (PUFA)) in reducing existing NAFLD in adults and children, and the results indicate that omega 3 is safe and effective at lowering liver fat in NAFLD patients. (15,16)
In this study, investigators aim to investigate if the SLP07, which is an investigational product that contains a blend of naturally occurring food-grade Bifidobacterium and Lactobacillus strains, omega-3 and vitamin E, is efficacious in liver function improvement in subjects with MAFLD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Active arm
Subjects will take 1 sachet of G-NiiB synbiotics formula (SLP07) daily for 3 months
G-NiiB synbiotics formula (SLP07)
SLP07 consists of a blend of food-grade Bifidobacterium and Lactobacillus as active probiotics, omega 3, and vitamin E.
Placebo arm
Subjects will take 1 sachet of active vitamin daily for 3 months
Active placebo
Active placebo contains 2mg of vitamin C with corn starch filler
Interventions
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G-NiiB synbiotics formula (SLP07)
SLP07 consists of a blend of food-grade Bifidobacterium and Lactobacillus as active probiotics, omega 3, and vitamin E.
Active placebo
Active placebo contains 2mg of vitamin C with corn starch filler
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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Microbiota I-Centre (MagIC)
UNKNOWN
GenieBiome Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Jessica Ching, PhD
Role: STUDY_DIRECTOR
GenieBiome Limited
Locations
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GenieBiome Limited
Hong Kong, , Hong Kong
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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MAFLD-RCT
Identifier Type: -
Identifier Source: org_study_id
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