Non-Alcoholic Fatty Liver DiseaseNCT05885373
A Clinical Study to Evaluate the Effect of SIM01 in Female With NAFLD
A study testing SIM01 in people with Non-Alcoholic Fatty Liver Disease, run by GenieBiome Limited at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- SIM01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2023to 31 Dec 2023
- 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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm, Open-label Clinical Study to Evaluate the Effect of SIM01 in Female Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
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.
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) In one study with a sample of 922 subjects using proton-magnetic resonance spectroscopy and transient elastography, 252 subjects had intrahepatic triglyceride content ≥5%, and 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)
At present, there is no standard pharmacologic therapy available for NAFLD currently. Current management for NAFLD includes diet and lifestyle changes, management of underlying metabolic risk factors and pharmacological therapies. Insulin-sensitizing medication such as Pioglitazone has been shown to improve histological NASH in terms of steatosis, inflammation, ballooning, NAFLD Activity Score (NAS score) and resolution of NASH. (9) However, the long-term efficacy and safety of Pioglitazone are unknown, and not all patients respond to Pioglitazone. Vitamin E is a fat-soluble compound which prevents liver injury by blocking intrinsic apoptotic pathways and by protecting against mitochondrial toxicity. (10) It also improves histological NASH in terms of steatosis, inflammation, ballooning, NAS score, and resolution of NASH at a dose of 800 IU/day. (9) However, the long-term safety of vitamin E is also an issue, because doses of 400 IU/day or higher have been associated with increased all-cause mortality. (11) While lifestyle management is often advocated, it is difficult to maintain. (12) Thus, it is important to explore new treatment strategies.
In general, NAFLD prevalence is higher in men compared to women. However, the prevalence of NAFLD in women is increasing in women over the past 10 years, (13) especially postmenopausal women who have greater NAFLD risk and higher rates of severe hepatic fibrosis relative to premenopausal women, and older women with NAFLD experience greater mortality than men. (14) A cohort study in Japan reported that women after the age of 70 had a higher prevalence of fatty liver than men (19.4% vs 14.9%). (15) Another cohort showed that gradual age-related increases in NAFLD prevalence were also observed in women (3.9% in the 21-39 age group; 7.6% in the 40-49 age group; 14.0% in the 50-59 age group; 18.9% in 60-69 age group), but not men. (15)
NAFLD is more prevalent in overweight and obese individuals; gut microbiota also plays a role in the development of insulin resistance, hepatic steatosis, necroinflammation and fibrosis. (16) On the other hand, probiotics can strengthen the intestinal wall, reducing its permeability, bacterial translocation, and endotoxemia according to animal and human studies. 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. (17) Probiotics have several anti-inflammatory effects that can contribute to their clinical benefits in NAFLD. (18)
The use of probiotics, prebiotics and synbiotics has been considered a potential and promising strategy to regulate the gut microbiota. (19, 20) Some clinical studies have been conducted to investigate the effects of probiotics on liver functions in NAFLD and NASH subjects. In general, the results of the trials (21-28) showed that the use of probiotics can reduce BMI, total fat percentage, total cholesterol, triglycerides, fasting insulin, alanine aminotransferase (ALT), aspartate transaminase (AST), tumour necrosis factor (TNF-α), interleukin (IL-6), liver stiffness et cetera.
This is a single-arm, open-label clinical trial for evaluating the efficacy of SIM01 on the reduction of liver biochemistry in 40 female subjects with NAFLD. All subjects will take 2 sachets of SIM01 daily for 3 months with monthly assessment on adverse event observation, and adherence to the study product throughout the study period. The change in CAP scores measured by the fibroscan, BMI, liver function and interleukin-6 will also be evaluated.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- SIM01
- Keywords
- Non-Alcoholic Fatty Liver Disease, Probiotics
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM01Dietary supplement
Also called G-NiiB Immunity formula
SIM01 consists of a blend of food-grade Bifidobacterium as active probiotics
| Study group | Role | What they receive |
|---|---|---|
| SIM01 | Experimental | 2 sachets daily for 3 months Receives: Dietary Supplement: SIM01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
Change in liver enzymes (alanine aminotransferase (ALT) and aspartate transaminase (AST)) across the study period.
The change in the level of liver enzymes.
Measured: 3 months
Change in fasting lipid and HbA1c 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
Change in interleukin-6 (IL-6) across the study period.
The change in the one of the immunity marker
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 posted1 Jun 2023
- Study start1 Mar 2023
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic 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
- Not applicable
- Intervention model
- Single group
- Model description
- All study subjects will receive the same study products.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenieBiome Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessica Ching, PhD, Study director, GenieBiome Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885373
- Sponsor's protocol ID
- GB-NAFLD
- Status last verified
- Feb 2024
- First submitted
- 14 Apr 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17565631Caldwell 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 21602530Wong 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 20460905Chitturi 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 21199528Sanyal AJ, Chalasani N, Kowdley KV, McCullough A, Diehl AM, Bass NM, Neuschwander-Tetri BA, Lavine JE, Tonascia J, Unalp A, Van Natta M, Clark J, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; NASH CRN. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010 May 6;362(18):1675-85. doi: 10.1056/NEJMoa0907929. Epub 2010 Apr 28.
PubMed 20427778Soden JS, Devereaux MW, Haas JE, Gumpricht E, Dahl R, Gralla J, Traber MG, Sokol RJ. Subcutaneous vitamin E ameliorates liver injury in an in vivo model of steatocholestasis. Hepatology. 2007 Aug;46(2):485-95. doi: 10.1002/hep.21690.
PubMed 17659596Miller ER 3rd, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005 Jan 4;142(1):37-46. doi: 10.7326/0003-4819-142-1-200501040-00110. Epub 2004 Nov 10.
PubMed 15537682Rodriguez-Hernandez H, Cervantes-Huerta M, Rodriguez-Moran M, Guerrero-Romero F. Decrease of aminotransferase levels in obese women is related to body weight reduction, irrespective of type of diet. Ann Hepatol. 2011 Oct-Dec;10(4):486-92.
PubMed 21911890Arshad T, Golabi P, Paik J, Mishra A, Younossi ZM. Prevalence of Nonalcoholic Fatty Liver Disease in the Female Population. Hepatol Commun. 2018 Nov 27;3(1):74-83. doi: 10.1002/hep4.1285. eCollection 2019 Jan.
PubMed 30619996DiStefano JK. NAFLD and NASH in Postmenopausal Women: Implications for Diagnosis and Treatment. Endocrinology. 2020 Oct 1;161(10):bqaa134. doi: 10.1210/endocr/bqaa134.
PubMed 32776116Hamaguchi M, Kojima T, Ohbora A, Takeda N, Fukui M, Kato T. Aging is a risk factor of nonalcoholic fatty liver disease in premenopausal women. World J Gastroenterol. 2012 Jan 21;18(3):237-43. doi: 10.3748/wjg.v18.i3.237.
PubMed 22294826
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Study to Evaluate the Effect of SIM01 in Female Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT05885373
- Acronym / sponsor ID
- GB-NAFLD
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Non-Alcoholic Fatty Liver Disease, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GenieBiome LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Jun 2023 (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 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.
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) In one study with a sample of 922 subjects using proton-magnetic resonance spectroscopy and transient elastography, 252 subjects had intrahepatic triglyceride content ≥5%, and 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)
At present, there is no standard pharmacologic therapy available for NAFLD currently. Current management for NAFLD includes diet and lifestyle changes, management of underlying metabolic risk factors and pharmacological therapies. Insulin-sensitizing medication such as Pioglitazone has been shown to improve histological NASH in terms of steatosis, inflammation, ballooning, NAFLD Activity Score (NAS score) and resolution of NASH. (9) However, the long-term efficacy and safety of Pioglitazone are unknown, and not all patients respond to Pioglitazone. Vitamin E is a fat-soluble compound which prevents liver injury by blocking intrinsic apoptotic pathways and by protecting against mitochondrial toxicity. (10) It also improves histological NASH in terms of steatosis, inflammation, ballooning, NAS score, and resolution of NASH at a dose of 800 IU/day. (9) However, the long-term safety of vitamin E is also an issue, because doses of 400 IU/day or higher have been associated with increased all-cause mortality. (11) While lifestyle management is often advocated, it is difficult to maintain. (12) Thus, it is important to explore new treatment strategies.
In general, NAFLD prevalence is higher in men compared to women. However, the prevalence of NAFLD in women is increasing in women over the past 10 years, (13) especially postmenopausal women who have greater NAFLD risk and higher rates of severe hepatic fibrosis relative to premenopausal women, and older women with NAFLD experience greater mortality than men. (14) A cohort study in Japan reported that women after the age of 70 had a higher prevalence of fatty liver than men (19.4% vs 14.9%). (15) Another cohort showed that gradual age-related increases in NAFLD prevalence were also observed in women (3.9% in the 21-39 age group; 7.6% in the 40-49 age group; 14.0% in the 50-59 age group; 18.9% in 60-69 age group), but not men. (15)
NAFLD is more prevalent in overweight and obese individuals; gut microbiota also plays a role in the development of insulin resistance, hepatic steatosis, necroinflammation and fibrosis. (16) On the other hand, probiotics can strengthen the intestinal wall, reducing its permeability, bacterial translocation, and endotoxemia according to animal and human studies. 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. (17) Probiotics have several anti-inflammatory effects that can contribute to their clinical benefits in NAFLD. (18)
The use of probiotics, prebiotics and synbiotics has been considered a potential and promising strategy to regulate the gut microbiota. (19, 20) Some clinical studies have been conducted to investigate the effects of probiotics on liver functions in NAFLD and NASH subjects. In general, the results of the trials (21-28) showed that the use of probiotics can reduce BMI, total fat percentage, total cholesterol, triglycerides, fasting insulin, alanine aminotransferase (ALT), aspartate transaminase (AST), tumour necrosis factor (TNF-α), interleukin (IL-6), liver stiffness et cetera.
This is a single-arm, open-label clinical trial for evaluating the efficacy of SIM01 on the reduction of liver biochemistry in 40 female subjects with NAFLD. All subjects will take 2 sachets of SIM01 daily for 3 months with monthly assessment on adverse event observation, and adherence to the study product throughout the study period. The change in CAP scores measured by the fibroscan, BMI, liver function and interleukin-6 will also be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All study subjects will receive the same study products.
| Arm | Type | Receives |
|---|---|---|
| SIM01 | Experimental | Dietary Supplement: SIM012 sachets daily for 3 months |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| SIM01Also: G-NiiB Immunity formulaSIM01 consists of a blend of food-grade Bifidobacterium as active probiotics | Dietary supplement | SIM01 |
Primary outcome
Change in Controlled Attenuation Parameter (CAP) score by fibroscan after taking SIM01 for 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.
5 secondary outcomes
Change in liver enzymes (alanine aminotransferase (ALT) and aspartate transaminase (AST)) across the study period.
Time frame: 3 months
Change in fasting lipid and HbA1c 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
Change in interleukin-6 (IL-6) 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 22 Feb 2024.
- 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 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 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 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 20427778Sanyal AJ, Chalasani N, Kowdley KV, McCullough A, Diehl AM, Bass NM, Neuschwander-Tetri BA, Lavine JE, Tonascia J, Unalp A, Van Natta M, Clark J, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; NASH CRN. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010 May 6;362(18):1675-85. doi: 10.1056/NEJMoa0907929. Epub 2010 Apr 28.
- Background: PubMed 17659596Soden JS, Devereaux MW, Haas JE, Gumpricht E, Dahl R, Gralla J, Traber MG, Sokol RJ. Subcutaneous vitamin E ameliorates liver injury in an in vivo model of steatocholestasis. Hepatology. 2007 Aug;46(2):485-95. doi: 10.1002/hep.21690.
- Background: PubMed 15537682Miller ER 3rd, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005 Jan 4;142(1):37-46. doi: 10.7326/0003-4819-142-1-200501040-00110. Epub 2004 Nov 10.
- Background: PubMed 21911890Rodriguez-Hernandez H, Cervantes-Huerta M, Rodriguez-Moran M, Guerrero-Romero F. Decrease of aminotransferase levels in obese women is related to body weight reduction, irrespective of type of diet. Ann Hepatol. 2011 Oct-Dec;10(4):486-92.
- 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 SIM01 in people with Non-Alcoholic 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 4 inclusion and 8 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 22 Feb 2024. 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. 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?
Change in Controlled Attenuation Parameter (CAP) score by fibroscan after taking SIM01 for 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 NCT05885373, which also lists 28 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 22 Feb 2024.