Metabolic Dysfunction-Associated Fatty Liver DiseaseMAFLD-RCTNCT06537882
Evaluate the Effect of Synbiotics on MAFLD
A study testing G-NiiB synbiotics formula (SLP07) in people with Metabolic Dysfunction-Associated Fatty Liver Disease, run by GenieBiome Limited at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Fatty Liver Disease
- What is being tested?
- G-NiiB synbiotics formula (SLP07)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 May 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Randomized Placebo-controlled Study to Evaluate the Effect of Synbiotics SLP07 on Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD-RCT)
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.
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide.(1) The prevalence of NAFLD is estimated to be about 20%-30% in the Western world (2) and increasing in Asia. The prevalence of NAFLD across Asia varies from 5% to 40%.(3,4) The population prevalence of NAFLD in Hong Kong Chinese was 27.3%.(1) NAFLD may progress to non-alcoholic steatohepatitis (NASH), cirrhosis, liver failure and liver cancer, and is believed to be the leading etiology for cryptogenic cirrhosis.(5,6) NAFLD is also strongly associated with obesity and metabolic syndrome and is shown to be an independent cardiovascular risk factor.(7,8) Recently, a consensus by an international panel of experts recommended a change in name for NAFLD to metabolic dysfunction associated with fatty liver disease (MAFLD).(9) Patients who fulfil the MAFLD criteria have more severe metabolic and liver disease than those who fulfil the NAFLD criteria alone. At present, there is no standard pharmacologic therapy available for NAFLD or MAFLD currently.
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.
- Being tested
- G-NiiB synbiotics formula (SLP07), Active placebo
- Keywords
- Metabolic dysfunction-Associated Fatty Liver Disease, Synbiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 placeboDietary supplement
Active placebo contains 2mg of vitamin C with corn starch filler
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Active comparator | Subjects will take 1 sachet of G-NiiB synbiotics formula (SLP07) daily for 3 months Receives: Dietary Supplement: G-NiiB synbiotics formula (SLP07) |
| Placebo arm | Placebo comparator | Subjects will take 1 sachet of active vitamin daily for 3 months Receives: Dietary Supplement: Active placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (8)
Percentage of participants with improvement in steatohepatitis across the study period.
The percentage of improvement in steatohepatitis compared to the baseline
Measured: 3 months
Change in lipid profile across the study period.
The change in the level of lipid profiles
Measured: 3 months
Change of body mass index (BMI) across the study period.
The change of body weight and body height
Measured: 3 months
Change of body waist circumference across the study period.
The change of waist circumference
Measured: 3 months
Adverse events reported during the study period.
The adverse events reported throughout the study
Measured: 3 months
Changes in faecal microbial profiling across 16 weeks
The change of microbial profile in stool compared to baseline
Measured: 3 months
Change of CAP score across the study period
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.
Measured: 3 months
Change of liver stiffness (measured in kPa) across the study period
The change of liver stiffness (measured in kPa)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start22 May 2024
- Primary completion7 Jan 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Metabolic Dysfunction-Associated Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All subjects will be randomized into two groups to take SLP07 or placebo daily for 3 months with monthly assessment.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenieBiome Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Microbiota I-Centre (MagIC)
- Responsible party
- Sponsor
- Investigators
- Jessica Ching, PhD, Study director, GenieBiome Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537882
- Sponsor's protocol ID
- MAFLD-RCT
- Acronym
- MAFLD-RCT
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21846782Bellentani 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.
PubMed 20460905Amarapurkar 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.
PubMed 17565631Chitturi 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.
PubMed 21199528Caldwell 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.
PubMed 10051466Farrell 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.
PubMed 16447287Hamaguchi 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.
PubMed 17461452Wong 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.
PubMed 21602530Eslam 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.
PubMed 32044314Loguercio 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.
PubMed 12190198Solga 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.
PubMed 12713883Eslamparast T, Eghtesad S, Hekmatdoost A, Poustchi H. Probiotics and Nonalcoholic Fatty liver Disease. Middle East J Dig Dis. 2013 Jul;5(3):129-36.
PubMed 24829682Pandey 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.
PubMed 26604335Yadav 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.
PubMed 35015145Jump 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.
PubMed 28723414
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Placebo-controlled Study to Evaluate the Effect of Synbiotics SLP07 on Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD-RCT)
- ClinicalTrials.gov ID
- NCT06537882
- Acronym / sponsor ID
- MAFLD-RCT / MAFLD-RCT
- Keywords
- Metabolic dysfunction-Associated Fatty Liver Disease, Synbiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- GenieBiome LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Microbiota I-Centre (MagIC)
- Study start
- 22 May 2024 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide.(1) The prevalence of NAFLD is estimated to be about 20%-30% in the Western world (2) and increasing in Asia. The prevalence of NAFLD across Asia varies from 5% to 40%.(3,4) The population prevalence of NAFLD in Hong Kong Chinese was 27.3%.(1) NAFLD may progress to non-alcoholic steatohepatitis (NASH), cirrhosis, liver failure and liver cancer, and is believed to be the leading etiology for cryptogenic cirrhosis.(5,6) NAFLD is also strongly associated with obesity and metabolic syndrome and is shown to be an independent cardiovascular risk factor.(7,8) Recently, a consensus by an international panel of experts recommended a change in name for NAFLD to metabolic dysfunction associated with fatty liver disease (MAFLD).(9) Patients who fulfil the MAFLD criteria have more severe metabolic and liver disease than those who fulfil the NAFLD criteria alone. At present, there is no standard pharmacologic therapy available for NAFLD or MAFLD currently.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All subjects will be randomized into two groups to take SLP07 or placebo daily for 3 months with monthly assessment.
| Arm | Type | Receives |
|---|---|---|
| Active arm | Active comparator | Dietary Supplement: G-NiiB synbiotics formula (SLP07)Subjects will take 1 sachet of G-NiiB synbiotics formula (SLP07) daily for 3 months |
| Placebo arm | Placebo comparator | Dietary Supplement: Active placeboSubjects will take 1 sachet of active vitamin daily for 3 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-NiiB synbiotics formula (SLP07)SLP07 consists of a blend of food-grade Bifidobacterium and Lactobacillus as active probiotics, omega 3, and vitamin E. | Dietary supplement | Active arm |
| Active placeboActive placebo contains 2mg of vitamin C with corn starch filler | Dietary supplement | Placebo arm |
Primary outcome
Percentage of participants with a reduction of at least 1 grade of steatosis AND/OR >10% reduction in CAP scores at 3 months
Time frame: 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.
8 secondary outcomes
Percentage of participants with improvement in steatohepatitis across the study period.
Time frame: 3 months
Change in lipid profile across the study period.
Time frame: 3 months
Change of body mass index (BMI) across the study period.
Time frame: 3 months
Change of body waist circumference across the study period.
Time frame: 3 months
Adverse events reported during the study period.
Time frame: 3 months
Changes in faecal microbial profiling across 16 weeks
Time frame: 3 months
Change of CAP score across the study period
Time frame: 3 months
Change of liver stiffness (measured in kPa) across the study period
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 21846782Wong 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.
- Background: PubMed 20460905Bellentani 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.
- Background: PubMed 17565631Amarapurkar 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.
- Background: PubMed 21199528Chitturi 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.
- Background: PubMed 10051466Caldwell 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.
- Background: PubMed 16447287Farrell 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.
- Background: PubMed 17461452Hamaguchi 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.
- Background: PubMed 21602530Wong 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.
- Background: PubMed 32044314Eslam 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.
- Background: PubMed 12190198Loguercio 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.
- Background: PubMed 12713883Solga 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.
- Background: PubMed 24829682Eslamparast T, Eghtesad S, Hekmatdoost A, Poustchi H. Probiotics and Nonalcoholic Fatty liver Disease. Middle East J Dig Dis. 2013 Jul;5(3):129-36.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Ching, PhD study director
GenieBiome Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-NiiB synbiotics formula (SLP07) in people with Metabolic Dysfunction-Associated Fatty Liver Disease, run by GenieBiome Limited at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with a reduction of at least 1 grade of steatosis AND/OR >10% reduction in CAP scores at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06537882, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.