An interventional study of Placebo and Probiotics in Non-Alcoholic Fatty Liver Disease, sponsored by GenMont Biotech Incorporation. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by GenMont Biotech Incorporation · Not applicable, Interventional, and Supportive care
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 48 studies in Non-alcoholic Fatty Liver Disease with a site in Taiwan — 12 open to participants now, 16 under way, 7 of them phase 3. Non-alcoholic Fatty Liver Disease · Taiwan.
Among the 48 studies in Non-alcoholic Fatty Liver Disease with a site in Taiwan, this one is the 31st largest by enrollment of the 41 interventional ones that give a count, is one of 7 that started in 2022, is one of 13 with no phase, and was the 30th registered.
1,618 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 323 are open to participants now.
Browse Non-alcoholic Fatty Liver Disease studies →12 of the 48 studies in Non-alcoholic Fatty Liver Disease with a site in Taiwan are open now. Recruiting first, the newest first:
GlaxoSmithKline · Sites in Taiwan, United States, Australia and 6 more countries
Ages 18–75
Eli Lilly and Company · Sites in Taiwan, United States, Argentina and 31 more countries
Ages 18+
National Taiwan University Hospital · Sites in Taiwan
Ages 18+
Chang Gung Memorial Hospital · Sites in Taiwan
Ages 20+
Hoffmann-La Roche · Sites in Taiwan, United States, Argentina and 22 more countries
Ages 18–75
A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →
Of the 220 Non-alcoholic Fatty Liver Disease studies recruiting now, 66 (30%) set no upper age limit and 125 (57%) stop at 75 or younger; 27 take children under 18; 55 take healthy volunteers.
This study: 20 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
48 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 7 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 70 is above the median of 60 across 1,177 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Median enrollment 145 across the 41 interventional studies, 800 across the 7 observational. Of the 28 that completed or were terminated, 17 (61%) have results posted.
This tab as a report to print or save as PDF → With an account.
30 of 48 have an industry lead sponsor. The 10 most frequent:
GenMont Biotech Incorporation is the lead sponsor of 11 studies on the registry; none are open to participants now.
GenMont Biotech Incorporation has 1 study filed under Non-alcoholic Fatty Liver Disease — fewer than ten, so there is no comparison to draw.
1 of the studies in Non-alcoholic Fatty Liver Disease with a site in Taiwan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05956379National Taiwan University HospitalChronic Hepatitis B Patients With Concurrent MAFLD: Cohort Study and Exercise Intervention. | 2027-07-31 |
Add it to your calendar (.ics) → With an account.
Among the 48 studies in Non-alcoholic Fatty Liver Disease with a site in Taiwan, from their registry updates:
This tab as a report to print or save as PDF → With an account.
In this study, the improvement of the clinical status of early-stage non-alcoholic fatty liver disease (NAFLD) patients after the probiotic intervention will be assessed. And the mechanism of probiotics to prevent the progression of illness would be investigated. The chronic inflammation status, systemic oxidative stress, metabolism of carbohydrates and lipid, and gut microbiota of NAFLD patients will also be analyzed.
Uncontrolled NAFLD evolves in Non-Alcoholic SteatoHepatitis (NASH), cirrhosis and liver cancer. Early intervention to prevent the progression of illness of NAFLD is very important. From 2005 to 2018, 15 clinical trials concluded that multiple-strain probiotics significantly reduced the liver inflammation index and blood lipids in NAFLD patients. Many reports indicated that NAFLD-associated risk factors, such as chronic inflammation, oxidative stress, insulin resistance, dyslipidemia, and obesity are closely correlated with gut microbiota. Some substances (such as endotoxin and alcohol) produced by harmful gut bacteria caused the progression of the illness of NAFLD.
Three strains are Genmont® Normal Lactobacillus (GMNL) which were divided from natural environments, included Lactobacillus reuteri GMNL-263 (heat-killed) and GMNL-89 (alive) and Lactobacillus rhamnosus GMNL-74 ( alive). They are all isolated from the gastrointestinal tract of healthy Taiwanese and were known as common food material worldwide. The previous clinical research on probiotic consumption in type 2 Diabetes mellitus patients under normal drug treatment was conducted in Changhua Christian Hospital. Results showed that L. reuteri GMNL-263 was able to stabilize the weight and blood pressure of patients. L. reuteri GMNL-89 had a stable effect on glycated hemoglobin. There was no adverse reaction when probiotics combining with type 2 diabetes drugs. Meanwhile, L. rhamnosus GMNL-74 was observed to reduce weight gain in obese mice. In this clinical study, The anti-liver inflammation effect of consumption of Lactobacillus sachet in NAFLD patients will be demonstrated at baseline, 3 months and 6 months. In this clinical study, the anti-liver inflammation effect of consumption of Lactobacillus sachet in NAFLD patients will be demonstrated at baseline, 3 months and 6 months to understand the impact of the probiotics on NAFLD. Since the treatment of fatty liver should focus on controlling weight, blood sugar, and blood fat, the relevant clinical indexes will also be investigated.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects received two placebo sachets per day
Other: Placebo
Subjects received two probiotic sachets per day
Dietary Supplement: Probiotics
Same Additives to Probiotic group but replace probiotics with Corn starch and Maltodextrin.
Also known as: Control group
Multi-strain probiotic supplement includes Lactobacillus reuteri GMNL-263 (heat-killed) and GMNL-89 (alive) and Lactobacillus rhamnosus GMNL-74 ( alive).
Also known as: Test group
Serum ALT (Alanine Aminotransferase) level at baseline
The number of patients will be enrolled with the concentration of ALT (Alanine Aminotransferase) ranging from 60 to 300 U/mL in serum.
Time frame: baseline
Change from baseline in Serum ALT (Alanine Aminotransferase) level at 3-months
Fasting blood samples will be collected to examine the variation of ALT (Alanine Aminotransferase).
Time frame: 3-months
Change from baseline in Serum ALT (Alanine Aminotransferase) level at 6-months
Fasting blood samples will be collected to examine the variation of ALT (Alanine Aminotransferase).
Time frame: 6-months
Change from baseline in BMI (Body Mass index) at 3-months
BMI will be calculated with weight and height combined in kg/m\^2, the weight will be measured in kilograms and the height will be recorded in centimeters.
Time frame: 3-months
Change from baseline in BMI (Body Mass index) at 6-months
BMI will be calculated with weight and height combined in kg/m\^2, the weight will be measured in kilograms and the height will be recorded in centimeters.
Time frame: 6-months
Change from baseline in Waist and hip circumference at 3-months
Waist and hip circumference will take down in centimeters.
Time frame: 3-months
Change from baseline in Waist and hip circumference at 6-months
Waist and hip circumference will take down in centimeters.
Time frame: 6-months
Change from baseline in blood pressure at 3-months
The unit of measurement of blood pressure is mmHg. Both systolic and diastolic blood pressure will be measured.
Time frame: 3-months
Change from baseline in blood pressure at 6-months
The unit of measurement of blood pressure is mmHg. Both systolic and diastolic blood pressure will be measured.
Time frame: 6-months
Change from baseline in the progress of the non-alcoholic fatty liver disease at 3-months
Utilizing abdominal ultrasound to detect the progress of Non-alcoholic fatty liver disease (NAFLD).
Time frame: 3-months
Change from baseline in the progress of the non-alcoholic fatty liver disease at 6-months
Utilizing abdominal ultrasound to detect the progress of Non-alcoholic fatty liver disease (NAFLD).
Time frame: 6-months
Change from baseline in levels of AST(Aspartate Aminotransferase) at 3-months
Fasting blood samples will be collected to examine changes from baseline in AST(Aspartate Aminotransferase) in IU/L at 3-months.
Time frame: 3-months
Change from baseline in levels of AST(Aspartate Aminotransferase) at 6-months
Fasting blood samples will be collected to examine changes from baseline in AST(Aspartate Aminotransferase) in IU/L at 6-months.
Time frame: 6-months
Change from baseline in the level of γ-GT (γ-Glutamyl Transpeptidase) at 3-months
Fasting blood samples will be collected to examine changes from baseline in γ-GT (γ-Glutamyl Transpeptidase) in IU/L at 3-months.
Time frame: 3-months
Change from baseline in the level of γ-GT (γ-Glutamyl Transpeptidase) at 6-months
Fasting blood samples will be collected to examine changes from baseline in γ-GT (γ-Glutamyl Transpeptidase) in IU/L at 6-months.
Time frame: 6-months
Change from baseline in the level of BUN (Blood Urea Nitrogen) at 3-months
Fasting blood samples will be collected to examine changes in BUN(Blood Urea Nitrogen) from baseline in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in the level of BUN (Blood Urea Nitrogen) at 6-months
Fasting blood samples will be collected to examine changes from baseline in BUN(Blood Urea Nitrogen) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in the level of CRE (Creatinine) at 3-months
Fasting blood samples will be collected to examine changes from baseline in CRE(Creatinine) in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in the level of CRE (Creatinine) at 6-months
Fasting blood samples will be collected to examine changes from baseline in CRE(Creatinine) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in levels of FBS (Fasting Blood Sugar) at 3-months
Fasting blood samples will be collected to examine changes from baseline in FBS(Fasting Blood Sugar) in mg/dL at 6-months.
Time frame: 3-months
Change from baseline in the level of FBS (Fasting Blood Sugar) at 6-months
Fasting blood samples will be collected to examine changes from baseline in FBS(Fasting Blood Sugar) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in levels of HbA1c (Hemoglobin A1C) at 3-months
Fasting blood samples will be collected to investigate the levels of HbA1c(Hemoglobin A1C) in % from baseline at 3-months.
Time frame: 3-months
Change from baseline in levels of HbA1c (Hemoglobin A1C) at 6-months
Fasting blood samples will be collected to investigate the levels of HbA1c(Hemoglobin A1C) in % from baseline at 6-months.
Time frame: 6-months
Change from baseline in levels of serum insulin at baseline
Fasting blood samples will be collected to examine variation in serum insulin in uIU/mL from baseline at 3-months.
Time frame: 3-months
Change from 3-months in levels of serum insulin at baseline
Fasting blood samples will be collected to examine variation in serum insulin in uIU/mL from baseline at 6-months.
Time frame: 6-months
Change from Baseline in levels of HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) at 3-months
HOMA-IR(Homeostatic Model Assessment for Insulin Resistance) will be calculated with insulin and glucose. (HOMA-IR=(insulin (mIU/L) and glucose (mg/dl))/405)
Time frame: 3-months
Change from baseline in levels of HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) at 6-months
HOMA-IR(Homeostatic Model Assessment for Insulin Resistance) will be calculated with insulin and glucose. (HOMA-IR=(insulin (mIU/L) and glucose (mg/dl))/405)
Time frame: 6-months
Change from baseline in levels of TC (Total Cholesterol) at 3-months
Fasting blood samples will be collected to examine variation from baseline in (Total Cholesterol) in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in levels of TC (Total Cholesterol) at 6-months
Fasting blood samples will be collected to examine variation from baseline in (Total Cholesterol) in mg/dL from baseline at 6-months.
Time frame: 6-months
Change from baseline in level of HDL (High density lipoprotein) at 3-months
Fasting blood samples will be collected to examine variation from baseline in HDL(High density lipoprotein) in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in level of HDL (High density lipoprotein) at 6-months
Fasting blood samples will be collected to examine variation from baseline in HDL(High density lipoprotein) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in level of LDL (Low density lipoprotein) at 3-months
Fasting blood samples will be collected to examine variation from baseline in LDL(Low density lipoprotein) in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in level of LDL (Low density lipoprotein) at 6-months
Fasting blood samples will be collected to examine variation from baseline in LDL(Low density lipoprotein) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in level of TG (Triglyceride) at 3-months
Fasting blood samples will be collected to examine variation from baseline in TG(Triglyceride) in mg/dL to 3-months.
Time frame: 3-months
Change from baseline in level of TG (Triglyceride) at 6-months
Fasting blood samples will be collected to examine variation from baseline in TG(Triglyceride) in mg/dL to 6-months.
Time frame: 6-months
Change from baseline in level of hs-CRP (high-sensitivity C-reactive protein) at 3-months
Blood samples will be collected to examine variation from baseline in hs-CRP(high-sensitivity C-reactive protein) in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in level of hs-CRP (high-sensitivity C-reactive protein) at 6-months
Blood samples will be collected to examine variation from baseline in hs-CRP(high-sensitivity C-reactive protein) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in level of TNF-α (Tumor necrosis factor-α) at 3-months
Blood samples will be collected to examine variation from baseline in TNF-α (Tumor necrosis factor-α) in pg/mL at 3-months.
Time frame: 3-months
Change from baseline in level of TNF-α (Tumor necrosis factor-α) at 6-months
Blood samples will be collected to examine variation from baseline in TNF-α (Tumor necrosis factor-α) in pg/mL at 6-months.
Time frame: 6-months
Change from baseline in level of IL-1β (Interleukin-1 β) at 3-months
Blood samples will be collected to examine variation from baseline in IL-1β(Interleukin-1 β) in pg/mL at 3-months.
Time frame: 3-months
Change from baseline in level of IL-1β (Interleukin-1 β) at 6-months
Blood samples will be collected to examine variation from baseline in IL-1β(Interleukin-1 β) in pg/mL at 6-months.
Time frame: 6-months
Change from baseline in level of IL-6 (Interleukin-6) at 3-months
Blood samples will be collected to examine variation from baseline in IL-6(Interleukin-6) in pg/mL at 3-months.
Time frame: 3-months
Change from baseline in level of IL-6 (Interleukin-6) at 6-months
Blood samples will be collected to examine variation from baseline in IL-6(Interleukin-6) in pg/mL at 6-months.
Time frame: 6-months
Change from baseline in level of LPS (Lipopolysaccharides) at 3-months
Blood samples will be collected to examine variation from baseline in LPS(Lipopolysaccharides) in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in level of LPS (Lipopolysaccharides) at 6-months
Blood samples will be collected to examine variation from baseline in LPS(Lipopolysaccharides) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in level of Leptin at 3-months
Blood samples will be collected to examine variation from baseline in Leptin in pg/mL at 3-months.
Time frame: 3-months
Change from baseline in level of Leptin at 6-months
Blood samples will be collected to examine variation from baseline in Leptin in pg/mL at 6-months.
Time frame: 6-months
Change from baseline in level of Adiponectin at 3-months
Blood samples will be collected to examine variation from baseline in Adiponectin in pg/mL at 3-months.
Time frame: 3-months
Change from baseline in level of Adiponectin at 6-months
Blood samples will be collected to examine variation from baseline in Adiponectin in pg/mL at 6-months.
Time frame: 6-months
Change from baseline in the level of SCFA (Short Chain Fatty Acids) at 6-months
Blood samples will be collected to examine variation from baseline in SCFA (Short Chain Fatty Acids) in ug/mL at 6-months.
Time frame: 6-months
Change from baseline in the level of TMAO (Trimethylamine N-oxide) at 6-months
Blood samples will be collected to examine variation from baseline in TMAO (Trimethylamine N-oxide) in μmol/L at 6-months.
Time frame: 6-months
Change from baseline in Self-questionnaire of Diet and lifestyle assessments at 6-months
The questionnaire will record dietary/drink preferences and other habits by the subject himself /herself, the content of the questionnaire includes vegetarian or not, the frequency if intake of tea, dairy, coffee or yakult intake, smoking habits, betel nuts intake and alcohol consumption.
Time frame: 6-months
Change from baseline in self-record of the International physical activity questionary (IPAQ) in physical assessment at 6-months
The questionnaire will be finished to record the laborious activity by the subject himself /herself before and after the treatment.
Time frame: 6-months
Change from baseline in gut microbiota at 6-months
The analysis of Gut microbiota will utilize DNA sequencing to investigate the intestinal microbiota through stool samples in subjects with NAFLD at 6-months.
Time frame: 6-months
Ran from Jul 2022 to primary completion in May 2024, 22 months.
Of 28 industry-sponsored interventional studies with no phase under Non-alcoholic Fatty Liver Disease, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 27. This study's 22 months is above that.
Counting every sponsor, half of 385 studies reached it within 25 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Non-alcoholic Fatty Liver Disease →
GenMont Biotech Incorporation