Liver ElastographyNCT07400367
Impact of a Probiotic Supplementation With Lifestyle Modification on Liver Steatosis, Fibrosis, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A study testing Probiotic product and Life style modification in people with Liver Elastography and Liver Steatosis, run by Fu Jen Catholic University Hospital at 2 sites in Taiwan.
Trial summary
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the new clinical term introduced in 2023 to redefine what was formerly known as Non-Alcoholic Fatty Liver Disease (NAFLD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Elastography, Liver Steatosis, Liver Function Test
- What is being tested?
- Probiotic product and Life style modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Apr 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ALT ≥ 60 U/L
- Liver steatosis identified by ultrasound
- Meet at least one cardiometabolic criteria:
- BMI ≥ 25 kg/m2 (Asian ≥23)
- Waist circumference: > 94cm (M) 80cm(F)
- Fasting blood glucose ≥ 100 mg/dL
Show all 13Show fewer
- HbA1c ≥ 5.7
- Receiving treatment of diabetes
- Receiving treatment of Hypertension
- Average home blood pressure: ≥ 130/85 mmHg
- TG ≥ 150 mg/dL
- HDL ≤ 40 mg/dL
- Receiving treatment of dyslipidemia
Who cannot join
- HBsAg(+)
- Anti-HCV (+)
- Cirrhosis
- Excessive alcohol intake ( Male over 210g/wk; Female over 140mg/wk)
- Could not rule out Autoimmune hepatitis (ANA, or AMA or ASMA (+))
- Could not rule out drug related hepatitis
Show all 21Show fewer
- Receiving drug that might induce liver steatosis:
- Glucocorticoids
- Amiodarone
- Tamoxifen
- Methotrexate
- Valproate
- Tetracycline
- Chemotherapeutic agents
- Receiving immune modulators or biologics
- Receiving antibiotics within 1 month
- Receiving any cancer treatment
- Have diagnosis of "Catastrophic Illness" defined by Health Administration of Taiwan
- eGFR<60
- Pregnancy
- Currently enrolled in other dietary or pharmacology clinical trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
Fu Jen Catholic University Hospital
New Taipei City
Kuan Wei Wu, +886-922-710-756, david800413@gmail.com
- Recruiting
Fu Jen Catholic University Hospital
New Taipei City
Kuwn Wei Wu, +886922710756, david800413@gmail.com
About this study
Official title: Impact of a Multi-strain Probiotic Supplementation With Lifestyle Modification on Liver Steatosis, Fibrosis, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the new clinical term introduced in 2023 to redefine what was formerly known as Non-Alcoholic Fatty Liver Disease (NAFLD). It is defined as fatty liver confirmed by imaging or biopsy, accompanied by at least one cardiometabolic risk factor (e.g., hyperglycemia, dyslipidemia, hypertension, or obesity). Its pathological progression ranges from simple steatosis to steatohepatitis, primarily driven by excessive energy intake, hepatic lipid accumulation, and insulin resistance.
MASLD is currently the most prevalent chronic liver disease globally, with a prevalence rate of approximately 30-40%. However, there is no satisfactory pharmacological treatment, leaving lifestyle modification as the primary therapeutic approach. Many patients struggle to effectively adjust their habits, leading to persistent hepatic inflammation and damage, which may eventually progress to end-stage diseases such as cirrhosis and hepatocellular carcinoma. In many developed countries, MASLD has become the leading indication for liver transplantation, imposing a heavy burden on healthcare systems.
Read more
Gut dysbiosis is closely linked to MASLD. An imbalance in the gut microbiota disrupts the gut-liver axis, leading to impaired intestinal mucosal barrier function. This allows bacterial components to enter the circulation, further triggering hepatic inflammation and abnormal lipid metabolism. Consequently, modulating the gut microbiota is considered a potential therapeutic strategy.
Over the past decade, probiotics, prebiotics, and synbiotics have been extensively studied as non-pharmacological treatments for NAFLD. Multiple studies indicate that these products can reduce liver enzymes (AST, ALT), insulin resistance (HOMA-IR), and inflammatory markers (hs-CRP, TNF-α). The most effective combinations typically involve Lactobacillus, Bifidobacterium, and Streptococcus, with a recommended duration of approximately 12 weeks. However, the impact of these products on liver fibrosis, hepatic fat accumulation, and cardiometabolic risk factors remains inconclusive.
The probiotic product to be tested consists of Lactobacillus salivarius AP-32, Lactobacillus rhamnosus bv-77, Bifidobacterium animalis CP-9, and Lactobacillus reuteri GL-104. This formulation complies with food safety regulations. In clinical studies, it had been proven as an effective adjuvant method that increased beneficial gut bacteria such as Akkermansia muciniphila and improved the control of blood glucose, lipids, and inflammatory markers.
Study Objectives
This study aims to investigate the efficacy of this probiotic product as an adjuvant therapy alongside lifestyle modifications in adult patients with MASLD. We will evaluate its impact on:
- The degree of liver fibrosis and steatosis
- Cardiometabolic risk factors (BMI, waist circumference, blood lipids, and blood glucose).
- Inflammatory markers.
- Gut microbiota composition.
- Conditions
- Liver Elastography, Liver Steatosis, Liver Function Test, Insulin Resistance, Cardiometabolic Risk Factors
- Being tested
- Probiotic product, Life style modification, placebo
- Keywords
- MASLD, Probiotics, Liver fibrosis, Liver steatosis
- Medical subject headings
- Fatty Liver, Insulin Resistance, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic productDietary supplement
The probiotic product contains Lactobacillus salivarius AP-32, Lactobacillus rhamnosus bv-77, Bifidobacterium animalis CP-9 and Lactobacillus reuteri GL-104
Life style modificationBehavioural
Life style modification of MASLD provided by an gastroenterologist in an outpatient s
placeboDietary supplement
placebo sachet looked and taste very similar to the probiotic product being tested
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receive the probiotic product one sachet per day and standard lifestyle modification education for MASLD by a gastroenterologist. Receives: Dietary Supplement: Probiotic product; Behavioral: Life style modification |
| Placebo | Active comparator | Receive the placebo one sachet per day and standard lifestyle modification education for MASLD by a gastroenterologist. Receives: Behavioral: Life style modification; Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in shear wave elastography (m/s) at 12 weeks
Change in liver fibrosis at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (28)
Change in ultrasound attenuation coefficient (dB/cm/MHz) at 12 weeks
Change in liver steatosis at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood LDL level (mg/dL) at 12 weeks
Change in blood LDL level (mg/dL) at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood HDL level (mg/dL) at 12 weeks
Change in blood HDL level (mg/dL) at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood total cholesterol level (mg/dL) at 12 weeks
Change in blood total cholesterol level (mg/dL) at 12 weeks
Measured: Time Frame: From enrollment to the end of treatment at 12 weeks
Change in blood triglycerides level (mg/dL) at 12 weeks
Change in blood triglycerides level (mg/dL) at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in HOMA-IR at 12 weeks
Change in insulin resistance at 12 week
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood fasting insulin level (μU/mL) at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood fasting glucose level (mg/dL) at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood AST level (U/L) at 12 weeks
Change in liver function test
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood ALT level (U/L) at 12 weeks
Change in liver function test
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood gamma-GT level (U/L) at 12 weeks
Change in liver function tests
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood alkaline phosphatase level (IU/L) at 12 weeks
Change in liver function tests
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood BUN level (mg/dL) at 12 weeks
Change in renal function
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood Creatinine level (mg/dL) at 12 weeks
Change in renal functions
Measured: From enrollment to the end of treatment at 12 weeks
Change in eGFR level (mL/min/1.73m^2) at 12 weeks
Change in renal function
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood albumin level (g/dL) at 12 weeks
Change in liver functions at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in platelet level (*10^3/uL) at 12 weeks
For the calculation of the chane of Fib-4 score at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in HbA1c level (%) at 12 weeks
Change in blood sugar control at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood hs-CRP level (mg/L) at 12 weeks
Change in systemic inflammation at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood IL-6 level (pg/mL) at 12 weeks
Change in systemic inflammation at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood TNF-alpha level (pg/mL) at 12 weeks
Change in systemic inflammation at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in Fib-4 score at 12 weeks
Change in liver fibrosis score at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in ARPI score at 12 weeks
Change in liver fibrosis score at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in NAFLD Fibrosis Score at 12 weeks
Change in liver fibrosis score at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in blood pressures (mmHg) at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in body weight (kg) at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in BMI (kg/m^2) at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Change in waist circumference (cm) at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Apr 2026
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Liver ElastographyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400367
- Sponsor's protocol ID
- FJUH114502
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identification data
Publications
Abhari K, Saadati S, Yari Z, Hosseini H, Hedayati M, Abhari S, Alavian SM, Hekmatdoost A. The effects of Bacillus coagulans supplementation in patients with non-alcoholic fatty liver disease: A randomized, placebo-controlled, clinical trial. Clin Nutr ESPEN. 2020 Oct;39:53-60. doi: 10.1016/j.clnesp.2020.06.020. Epub 2020 Jul 24.
PubMed 32859329Inoue K, Tsukuda S, Kayano H, Tanaka J, Heshiki A. A case of hypervascular renal capsule leiomyoma. Radiat Med. 2000 Sep-Oct;18(5):323-6.
PubMed 11128405Kumada T, Toyoda H, Ogawa S, Gotoh T, Yoshida Y, Yamahira M, Hirooka M, Koizumi Y, Hiasa Y, Tamai T, Kuromatsu R, Matsuzaki T, Suehiro T, Kamada Y, Sumida Y, Tanaka J, Shimizu M. Diagnostic performance of shear wave measurement in the detection of hepatic fibrosis: A multicenter prospective study. Hepatol Res. 2024 Sep;54(9):851-858. doi: 10.1111/hepr.14026. Epub 2024 Feb 13.
PubMed 38349813Farrow A, Farrow SC, Little R, Golding J. The repeatability of self-reported exposure after miscarriage. ALSPAC Study Team. Avon Longitudinal Study of Pregnancy and Childhood. Int J Epidemiol. 1996 Aug;25(4):797-806. doi: 10.1093/ije/25.4.797.
PubMed 8921459Jansson JH, Boman K, Brannstrom M, Nilsson TK. High concentration of thrombomodulin in plasma is associated with hemorrhage: a prospective study in patients receiving long-term anticoagulant treatment. Circulation. 1997 Nov 4;96(9):2938-43. doi: 10.1161/01.cir.96.9.2938.
PubMed 9386160Yang Y, Yang L, Wu J, Hu J, Wan M, Bie J, Li J, Pan D, Sun G, Yang C. Optimal probiotic combinations for treating nonalcoholic fatty liver disease: A systematic review and network meta-analysis. Clin Nutr. 2024 Jun;43(6):1224-1239. doi: 10.1016/j.clnu.2024.04.004. Epub 2024 Apr 13.
PubMed 38643738Wu J, Chen X, Qian J, Li G. Clinical improvement effect of regulating gut microbiota on metabolic dysfunction-associated steatotic liver disease: Systematic review and meta-analysis of randomized controlled trials. Clin Res Hepatol Gastroenterol. 2024 Aug;48(7):102397. doi: 10.1016/j.clinre.2024.102397. Epub 2024 Jun 13.
PubMed 38879003Sharma S, Tiwari N, Tanwar SS. The current findings on the gut-liver axis and the molecular basis of NAFLD/NASH associated with gut microbiome dysbiosis. Naunyn Schmiedebergs Arch Pharmacol. 2025 Sep;398(9):11541-11579. doi: 10.1007/s00210-025-04069-z. Epub 2025 Apr 9.
PubMed 40202676Ledru E, Diagbouga S, Tranchot-Diallo J, Cauchoix B, Yameogo M, Chami D, Soula G, Chiron JP. Eosinophils: a putative marker of immunodepression in HIV-infected African patients with tuberculosis? Trans R Soc Trop Med Hyg. 1994 Jan-Feb;88(1):117-8. doi: 10.1016/0035-9203(94)90531-2. No abstract available.
PubMed 7908766Su X, Chen S, Liu J, Feng Y, Han E, Hao X, Liao M, Cai J, Zhang S, Niu J, He S, Huang S, Lo K, Zeng F. Composition of gut microbiota and non-alcoholic fatty liver disease: A systematic review and meta-analysis. Obes Rev. 2024 Jan;25(1):e13646. doi: 10.1111/obr.13646. Epub 2023 Oct 9.
PubMed 37813400
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multi-strain Probiotic Supplementation With Lifestyle Modification on Liver Steatosis, Fibrosis, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- ClinicalTrials.gov ID
- NCT07400367
- Acronym / sponsor ID
- FJUH114502
- Conditions
- Liver Elastography, Liver Steatosis, Liver Function Test, Insulin Resistance, Cardiometabolic Risk Factors
- Keywords
- MASLD, Probiotics, Liver fibrosis, Liver steatosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 10 Feb 2026 (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.
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the new clinical term introduced in 2023 to redefine what was formerly known as Non-Alcoholic Fatty Liver Disease (NAFLD). It is defined as fatty liver confirmed by imaging or biopsy, accompanied by at least one cardiometabolic risk factor (e.g., hyperglycemia, dyslipidemia, hypertension, or obesity). Its pathological progression ranges from simple steatosis to steatohepatitis, primarily driven by excessive energy intake, hepatic lipid accumulation, and insulin resistance.
MASLD is currently the most prevalent chronic liver disease globally, with a prevalence rate of approximately 30-40%. However, there is no satisfactory pharmacological treatment, leaving lifestyle modification as the primary therapeutic approach. Many patients struggle to effectively adjust their habits, leading to persistent hepatic inflammation and damage, which may eventually progress to end-stage diseases such as cirrhosis and hepatocellular carcinoma. In many developed countries, MASLD has become the leading indication for liver transplantation, imposing a heavy burden on healthcare systems.
Gut dysbiosis is closely linked to MASLD. An imbalance in the gut microbiota disrupts the gut-liver axis, leading to impaired intestinal mucosal barrier function. This allows bacterial components to enter the circulation, further triggering hepatic inflammation and abnormal lipid metabolism. Consequently, modulating the gut microbiota is considered a potential therapeutic strategy.
Over the past decade, probiotics, prebiotics, and synbiotics have been extensively studied as non-pharmacological treatments for NAFLD. Multiple studies indicate that these products can reduce liver enzymes (AST, ALT), insulin resistance (HOMA-IR), and inflammatory markers (hs-CRP, TNF-α). The most effective combinations typically involve Lactobacillus, Bifidobacterium, and Streptococcus, with a recommended duration of approximately 12 weeks. However, the impact of these products on liver fibrosis, hepatic fat accumulation, and cardiometabolic risk factors remains inconclusive.
The probiotic product to be tested consists of Lactobacillus salivarius AP-32, Lactobacillus rhamnosus bv-77, Bifidobacterium animalis CP-9, and Lactobacillus reuteri GL-104. This formulation complies with food safety regulations. In clinical studies, it had been proven as an effective adjuvant method that increased beneficial gut bacteria such as Akkermansia muciniphila and improved the control of blood glucose, lipids, and inflammatory markers.
Study Objectives
This study aims to investigate the efficacy of this probiotic product as an adjuvant therapy alongside lifestyle modifications in adult patients with MASLD. We will evaluate its impact on:
- The degree of liver fibrosis and steatosis
- Cardiometabolic risk factors (BMI, waist circumference, blood lipids, and blood glucose).
- Inflammatory markers.
- Gut microbiota composition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Probiotic product, Behavioral: Life style modificationReceive the probiotic product one sachet per day and standard lifestyle modification education for MASLD by a gastroenterologist. |
| Placebo | Active comparator | Behavioral: Life style modification, Dietary Supplement: placeboReceive the placebo one sachet per day and standard lifestyle modification education for MASLD by a gastroenterologist. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ALT ≥ 60 U/L
- Liver steatosis identified by ultrasound
- Meet at least one cardiometabolic criteria:
Key exclusion criteria (21 listed)
- HBsAg(+)
- Anti-HCV (+)
- Cirrhosis
- Excessive alcohol intake ( Male over 210g/wk; Female over 140mg/wk)
- Could not rule out Autoimmune hepatitis (ANA, or AMA or ASMA (+))
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 |
|---|---|---|
| Probiotic productThe probiotic product contains Lactobacillus salivarius AP-32, Lactobacillus rhamnosus bv-77, Bifidobacterium animalis CP-9 and Lactobacillus reuteri GL-104 | Dietary supplement | Intervention |
| Life style modificationLife style modification of MASLD provided by an gastroenterologist in an outpatient s | Behavioural | Intervention, Placebo |
| placeboplacebo sachet looked and taste very similar to the probiotic product being tested | Dietary supplement | Placebo |
Primary outcome
Change in shear wave elastography (m/s) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in liver fibrosis at 12 weeks
28 secondary outcomes
Change in ultrasound attenuation coefficient (dB/cm/MHz) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood LDL level (mg/dL) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood HDL level (mg/dL) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood total cholesterol level (mg/dL) at 12 weeks
Time frame: Time Frame: From enrollment to the end of treatment at 12 weeks
Change in blood triglycerides level (mg/dL) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in HOMA-IR at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood fasting insulin level (μU/mL) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood fasting glucose level (mg/dL) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood AST level (U/L) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood ALT level (U/L) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood gamma-GT level (U/L) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood alkaline phosphatase level (IU/L) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood BUN level (mg/dL) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood Creatinine level (mg/dL) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in eGFR level (mL/min/1.73m^2) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood albumin level (g/dL) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in platelet level (*10^3/uL) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in HbA1c level (%) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood hs-CRP level (mg/L) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood IL-6 level (pg/mL) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood TNF-alpha level (pg/mL) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in Fib-4 score at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in ARPI score at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in NAFLD Fibrosis Score at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in blood pressures (mmHg) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in body weight (kg) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in BMI (kg/m^2) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change in waist circumference (cm) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 32859329Abhari K, Saadati S, Yari Z, Hosseini H, Hedayati M, Abhari S, Alavian SM, Hekmatdoost A. The effects of Bacillus coagulans supplementation in patients with non-alcoholic fatty liver disease: A randomized, placebo-controlled, clinical trial. Clin Nutr ESPEN. 2020 Oct;39:53-60. doi: 10.1016/j.clnesp.2020.06.020. Epub 2020 Jul 24.
- Background: PubMed 11128405Inoue K, Tsukuda S, Kayano H, Tanaka J, Heshiki A. A case of hypervascular renal capsule leiomyoma. Radiat Med. 2000 Sep-Oct;18(5):323-6.
- Background: PubMed 38349813Kumada T, Toyoda H, Ogawa S, Gotoh T, Yoshida Y, Yamahira M, Hirooka M, Koizumi Y, Hiasa Y, Tamai T, Kuromatsu R, Matsuzaki T, Suehiro T, Kamada Y, Sumida Y, Tanaka J, Shimizu M. Diagnostic performance of shear wave measurement in the detection of hepatic fibrosis: A multicenter prospective study. Hepatol Res. 2024 Sep;54(9):851-858. doi: 10.1111/hepr.14026. Epub 2024 Feb 13.
- Background: PubMed 8921459Farrow A, Farrow SC, Little R, Golding J. The repeatability of self-reported exposure after miscarriage. ALSPAC Study Team. Avon Longitudinal Study of Pregnancy and Childhood. Int J Epidemiol. 1996 Aug;25(4):797-806. doi: 10.1093/ije/25.4.797.
- Background: PubMed 9386160Jansson JH, Boman K, Brannstrom M, Nilsson TK. High concentration of thrombomodulin in plasma is associated with hemorrhage: a prospective study in patients receiving long-term anticoagulant treatment. Circulation. 1997 Nov 4;96(9):2938-43. doi: 10.1161/01.cir.96.9.2938.
- Background: PubMed 38643738Yang Y, Yang L, Wu J, Hu J, Wan M, Bie J, Li J, Pan D, Sun G, Yang C. Optimal probiotic combinations for treating nonalcoholic fatty liver disease: A systematic review and network meta-analysis. Clin Nutr. 2024 Jun;43(6):1224-1239. doi: 10.1016/j.clnu.2024.04.004. Epub 2024 Apr 13.
- Background: PubMed 38879003Wu J, Chen X, Qian J, Li G. Clinical improvement effect of regulating gut microbiota on metabolic dysfunction-associated steatotic liver disease: Systematic review and meta-analysis of randomized controlled trials. Clin Res Hepatol Gastroenterol. 2024 Aug;48(7):102397. doi: 10.1016/j.clinre.2024.102397. Epub 2024 Jun 13.
- Background: PubMed 40202676Sharma S, Tiwari N, Tanwar SS. The current findings on the gut-liver axis and the molecular basis of NAFLD/NASH associated with gut microbiome dysbiosis. Naunyn Schmiedebergs Arch Pharmacol. 2025 Sep;398(9):11541-11579. doi: 10.1007/s00210-025-04069-z. Epub 2025 Apr 9.
- Background: PubMed 7908766Ledru E, Diagbouga S, Tranchot-Diallo J, Cauchoix B, Yameogo M, Chami D, Soula G, Chiron JP. Eosinophils: a putative marker of immunodepression in HIV-infected African patients with tuberculosis? Trans R Soc Trop Med Hyg. 1994 Jan-Feb;88(1):117-8. doi: 10.1016/0035-9203(94)90531-2. No abstract available.
- Background: PubMed 37813400Su X, Chen S, Liu J, Feng Y, Han E, Hao X, Liao M, Cai J, Zhang S, Niu J, He S, Huang S, Lo K, Zeng F. Composition of gut microbiota and non-alcoholic fatty liver disease: A systematic review and meta-analysis. Obes Rev. 2024 Jan;25(1):e13646. doi: 10.1111/obr.13646. Epub 2023 Oct 9.
- Individual participant dataSharing planned: Yes. de-identification data
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Not yet recruitingObservational study
Lifestyle, Dietary Patterns, and Cardiometabolic Risk in Metabolic Dysfunction-Associated Steatotic Liver Disease Among People Living With HIV
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), HIV Infections
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic product and Life style modification in people with Liver Elastography and Liver Steatosis, run by Fu Jen Catholic University Hospital at 2 sites 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 13 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kuan Wei Wu (+886-922-710-756, david800413@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in shear wave elastography (m/s) at 12 weeks (time frame: From enrollment to the end of treatment at 12 weeks). 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 NCT07400367, which also lists 10 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 6 Apr 2026.