Non-Alcoholic Fatty Liver DiseaseNCT05402449
To Evaluate the Beneficial Effect of Probiotics on NAFLD Patients and the Role of Gut Microbiota Modulation
A study testing Probiotics in people with Non-Alcoholic Fatty Liver Disease, run by GenMont Biotech Incorporation at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jul 2022to 31 May 2024
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Nonalcoholic fatty liver disease (NALFD) by ultrasound.
- The range of Alanine aminotransferase (ALT) blood test is 60-300 U/L
Who cannot join
- Alcoholic consumption (Female ≥ 10g/day or Male ≥ 20g/per)
- Patients with liver diseases, HBV(hepatitis B virus), HCV(hepatitis C virus), Primary Biliary Cholangitis.
- Autoimmune system disease
- Wilson's disease
- Hereditary hemochromatosis
- Patients with uncontrolled malignancy
Show all 10Show fewer
- The subject had previously received weight reduction surgery
- Taking Antibiotics, probiotics, or any other drugs that affect NAFLD or glucose and lipid metabolism in past 2 months
- Pregnant or lactating female patients
- Patient who have severe allergy to soybeans or peanuts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Clinical Efficacy of Probiotic in Patients With NAFLD
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.
Read the detailed description
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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Placebo, Probiotics
- Keywords
- Probiotic, Non-Alcoholic Fatty Liver Disease, gut microbiota
- 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.
PlaceboOther
Also called Control group
Same Additives to Probiotic group but replace probiotics with Corn starch and Maltodextrin.
ProbioticsDietary supplement
Also called Test group
Multi-strain probiotic supplement includes Lactobacillus reuteri GMNL-263 (heat-killed) and GMNL-89 (alive) and Lactobacillus rhamnosus GMNL-74 ( alive).
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Subjects received two placebo sachets per day Receives: Other: Placebo |
| Probiotic group | Experimental | Subjects received two probiotic sachets per day Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 6-months
Secondary outcomes (51)
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.
Measured: 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.
Measured: 6-months
Change from baseline in Waist and hip circumference at 3-months
Waist and hip circumference will take down in centimeters.
Measured: 3-months
Change from baseline in Waist and hip circumference at 6-months
Waist and hip circumference will take down in centimeters.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start14 Jul 2022
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trail
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenMont Biotech Incorporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fu Jen Catholic University Hospital
- Responsible party
- Sponsor
- Investigators
- Chi-Yang Chang, PhD, Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402449
- Sponsor's protocol ID
- NAFLD2022
- Status last verified
- Sep 2023
- First submitted
- 5 May 2022
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Clinical Efficacy of Probiotic in Patients With NAFLD
- ClinicalTrials.gov ID
- NCT05402449
- Acronym / sponsor ID
- NAFLD2022
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Probiotic, Non-Alcoholic Fatty Liver Disease, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- GenMont Biotech IncorporationIndustry (pharma, biotech, devices)
- Collaborators
- Fu Jen Catholic University Hospital
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 2 Jun 2022 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Trail
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: PlaceboSubjects received two placebo sachets per day |
| Probiotic group | Experimental | Dietary Supplement: ProbioticsSubjects received two probiotic sachets per day |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Nonalcoholic fatty liver disease (NALFD) by ultrasound.
- The range of Alanine aminotransferase (ALT) blood test is 60-300 U/L
Key exclusion criteria (10 listed)
- Alcoholic consumption (Female ≥ 10g/day or Male ≥ 20g/per)
- Patients with liver diseases, HBV(hepatitis B virus), HCV(hepatitis C virus), Primary Biliary Cholangitis.
- Autoimmune system disease
- Wilson's disease
- Hereditary hemochromatosis
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 |
|---|---|---|
| PlaceboAlso: Control groupSame Additives to Probiotic group but replace probiotics with Corn starch and Maltodextrin. | Other | Placebo group |
| ProbioticsAlso: Test groupMulti-strain probiotic supplement includes Lactobacillus reuteri GMNL-263 (heat-killed) and GMNL-89 (alive) and Lactobacillus rhamnosus GMNL-74 ( alive). | Dietary supplement | Probiotic group |
Primary outcome
Serum ALT (Alanine Aminotransferase) level at baseline
Time frame: baseline
The number of patients will be enrolled with the concentration of ALT (Alanine Aminotransferase) ranging from 60 to 300 U/mL in serum.
Change from baseline in Serum ALT (Alanine Aminotransferase) level at 3-months
Time frame: 3-months
Fasting blood samples will be collected to examine the variation of ALT (Alanine Aminotransferase).
Change from baseline in Serum ALT (Alanine Aminotransferase) level at 6-months
Time frame: 6-months
Fasting blood samples will be collected to examine the variation of ALT (Alanine Aminotransferase).
51 secondary outcomes
Change from baseline in BMI (Body Mass index) at 3-months
Time frame: 3-months
Change from baseline in BMI (Body Mass index) at 6-months
Time frame: 6-months
Change from baseline in Waist and hip circumference at 3-months
Time frame: 3-months
Change from baseline in Waist and hip circumference at 6-months
Time frame: 6-months
Change from baseline in blood pressure at 3-months
Time frame: 3-months
Change from baseline in blood pressure at 6-months
Time frame: 6-months
Change from baseline in the progress of the non-alcoholic fatty liver disease at 3-months
Time frame: 3-months
Change from baseline in the progress of the non-alcoholic fatty liver disease at 6-months
Time frame: 6-months
Change from baseline in levels of AST(Aspartate Aminotransferase) at 3-months
Time frame: 3-months
Change from baseline in levels of AST(Aspartate Aminotransferase) at 6-months
Time frame: 6-months
Change from baseline in the level of γ-GT (γ-Glutamyl Transpeptidase) at 3-months
Time frame: 3-months
Change from baseline in the level of γ-GT (γ-Glutamyl Transpeptidase) at 6-months
Time frame: 6-months
Change from baseline in the level of BUN (Blood Urea Nitrogen) at 3-months
Time frame: 3-months
Change from baseline in the level of BUN (Blood Urea Nitrogen) at 6-months
Time frame: 6-months
Change from baseline in the level of CRE (Creatinine) at 3-months
Time frame: 3-months
Change from baseline in the level of CRE (Creatinine) at 6-months
Time frame: 6-months
Change from baseline in levels of FBS (Fasting Blood Sugar) at 3-months
Time frame: 3-months
Change from baseline in the level of FBS (Fasting Blood Sugar) at 6-months
Time frame: 6-months
Change from baseline in levels of HbA1c (Hemoglobin A1C) at 3-months
Time frame: 3-months
Change from baseline in levels of HbA1c (Hemoglobin A1C) at 6-months
Time frame: 6-months
Change from baseline in levels of serum insulin at baseline
Time frame: 3-months
Change from 3-months in levels of serum insulin at baseline
Time frame: 6-months
Change from Baseline in levels of HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) at 3-months
Time frame: 3-months
Change from baseline in levels of HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) at 6-months
Time frame: 6-months
Change from baseline in levels of TC (Total Cholesterol) at 3-months
Time frame: 3-months
Change from baseline in levels of TC (Total Cholesterol) at 6-months
Time frame: 6-months
Change from baseline in level of HDL (High density lipoprotein) at 3-months
Time frame: 3-months
Change from baseline in level of HDL (High density lipoprotein) at 6-months
Time frame: 6-months
Change from baseline in level of LDL (Low density lipoprotein) at 3-months
Time frame: 3-months
Change from baseline in level of LDL (Low density lipoprotein) at 6-months
Time frame: 6-months
Change from baseline in level of TG (Triglyceride) at 3-months
Time frame: 3-months
Change from baseline in level of TG (Triglyceride) at 6-months
Time frame: 6-months
Change from baseline in level of hs-CRP (high-sensitivity C-reactive protein) at 3-months
Time frame: 3-months
Change from baseline in level of hs-CRP (high-sensitivity C-reactive protein) at 6-months
Time frame: 6-months
Change from baseline in level of TNF-α (Tumor necrosis factor-α) at 3-months
Time frame: 3-months
Change from baseline in level of TNF-α (Tumor necrosis factor-α) at 6-months
Time frame: 6-months
Change from baseline in level of IL-1β (Interleukin-1 β) at 3-months
Time frame: 3-months
Change from baseline in level of IL-1β (Interleukin-1 β) at 6-months
Time frame: 6-months
Change from baseline in level of IL-6 (Interleukin-6) at 3-months
Time frame: 3-months
Change from baseline in level of IL-6 (Interleukin-6) at 6-months
Time frame: 6-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 5 Jul 2024.
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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.
Chi-Yang Chang, PhD principal investigator
Fu Jen Catholic University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Non-Alcoholic Fatty Liver Disease, run by GenMont Biotech Incorporation at 1 site in Taiwan.
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 2 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 5 Jul 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 Taiwan. 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?
Serum ALT (Alanine Aminotransferase) level at baseline (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2024.