NCT07193927尚未招募不适用
Investigation of the Efficacy of a Probiotic Mixture in Subjects With Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in MASLD from baseline
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a specific probiotic mixture can improve liver health in adults with moderate metabolic dysfunction-associated steatotic liver disease (MASLD).
The main questions it aims to answer are:
Can the probiotics improve liver fat and stiffness as measured by non-invasive imaging (FibroScan® CAP and FAST scores)? Does the probiotic affect other health markers like cholesterol, blood sugar, inflammation, and gut bacteria?
Researchers will compare people taking the probiotic to those taking a placebo (a capsule with no active ingredients) to see if the probiotic has beneficial effects.
Participants will:
Be randomly assigned to take either the probiotic or placebo daily for 6 months.
Attend 3 study visits (at the start, 3 months, and 6 months). Provide blood and stool samples. Undergo liver scans (FibroScan®). Complete a health and nutrition questionnaire.
This study includes adults aged 18-65 with moderate MASLD and certain metabolic health conditions. Participants must not be pregnant, breastfeeding, or taking certain medications or supplements that could interfere with the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 18 to 65 years old
- •BMI 25.34,9kg/m2
- •Diagnosed with MASLD and CAP value > 268 dB/m evaluated by FibroScan®
- •High ALT levels (>43 U/L in males and >33 U/L in females)
- •Having at least three of the following features compatible with metabolic syndrome:
- •i. Waist circumference ≥ 102 cm in males and ≥ 88 cm in females. ii. Fasting serum glucose (≥ 5.6 mmol/L or 100 mg/dl). iii. Glycated haemoglobin (HbA1c ≥ 5.7%/ 39 mmol/L). iv. Diagnosed or treated for type 2 diabetes. v. High blood pressure (≥ 130/85 mmHg). vi. High plasma triglycerides (≥ 1.70 mmol/L or 150 mg/dl). vii. Lower plasma of High-Density Lipoprotein (HDL cholesterol) (≤ 1.0 mmol/L or 40 mg/dl for males and ≤ 1.3 mmol/L or 50 mg/dl for females).
- •Stable weight in the last 3 months (less than ± 4% weight variation).
- •Stable medication or intake of food supplements for a medical condition that can affect study outcomes according to the Investigator's judgement in the last three months prior to study entry (bile salt sequestrants are not permitted).
- •Not planning to change their dietary and lifestyle habits during the study.
- •Willing and able to provide informed consent and comply with study procedures.
排除标准
- •Fibrosis scores equal or higher than F2 (≥ 7.5 kPa).
- •History of acute or chronic hepatitis A, B or C, autoimmune hepatitis, drug-induced liver diseases, severe liver diseases.
- •Prior or pending liver transplantation.
- •Patients with at least one of the following concurrent conditions:
- •i. Type I diabetes ii. Uncontrolled type II diabetes (HbA1c >8%) iii. Hypertriglyceridemia > 350mg/dl iv. Human Immunodeficiency Virus (HIV) infection v. Diagnosis of hemochromatosis
- •Current use of pioglitazone, SGLT-2 inhibitors, or approved drugs for MASLD or steatohepatitis within 8 weeks.
- •Current use of bile salt sequestrants within 8 weeks.
- •Significant gastrointestinal disease, such as inframmatory bowel disease (IBD, short bowel syndrome, chronic or recurrent diarrhoea, coeliac condition.
- •Pancreatic failure, biliary dysfunction (including cholecystectomy and blood bilirubin abnormalities)
- •Thyroid dysfunction, as assessed by the investigator (clinical criteria)
- •History of:
- •i. Cardiovascular disease (ischemic heart disease, heart failure, cerebrovascular disease, periphreal vascular disease).
- •ii. Cancer or immunosuppression. iii. Gastrointestinal surgery in the previous year (with the exception of appendicitis).
- •Patients with a history of chronic alcohol or drug abuse: > 14 units/week for females and > 21 units/week for male
- •Chronic and heavy smoking (>20 cigarettes a day)
- •Regular intake (> 3 days/week) of other probiotics (including food complements or diary foods with other probiotic strains, e.g. Activia®, Actimel® or similar).
- •Intake of nutraceuticals with an effect on hepatic function such as > 500 mg/day omega-3 fatty acids, high-dose vitamin E supplements or milk thistle (sylibum marianum) extract ot their active ingredients (silymarin, silybin) regularly (> 7 days) in the 15 days before study entry.
- •Current use of systemic corticosteroids, androgens, clopidogrel, digoxin, acenocoumarol, warfarin, phenytoin, topiramate, lithium, tricyclic antidepressants, MAOIs or second-generation antipsychotics, amiodarone, tamixofen and/or diltiazem.
- •History of use (> 3 days) of oral or parenteral antibiotics one month before the study initiation.
- •Chronic use of laxatives.
- •Debilitating illnesses (advanced liver or kidney disease, severe depression, psychotic symptoms, neurological diseases).
- •Current pregnancy (positive urine test) or planning to become pregnant during the study.
- •Breastfeeding at the time of eligibility assessment.
- •Patients who have participated in a clinical trial in the six-month period before the study.
结局指标
主要结局
Changes in MASLD from baseline
时间窗: From enrollment to the end of treatment at 6 months.
Evaluated by CAP (controlled attenuation parameter, dB/m) and FAST score \[determined with FibroScan®\]
次要结局
- Changes from baseline in Liver Fibrosis (kPa)(From enrollment to the end of treatment at 6 months.)
- Changes form baseline in MASLD related index - FLI(From enrollment to the end of treatment at 6 months.)
- Changes form baseline in MASLD related index - FIB-4(From enrollment to the end of treatment at 6 months.)
- Changes form baseline in MASLD related index - APRI(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in metabolic syndrome score (siMS)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in weight (kg)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in height (cm)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in Body Mass Index (BMI)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in waist circumference (cm)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in hip circumference (cm)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in waist/hip ratio(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in systolic and diastolic blood pressure.(From entollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of blood-based cell profile.(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum liver enzyme concentrations(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis insulin resistance-related variables(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of cholesterol and fatty acid concentrations:(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of high-sensitivity C-reactive protein (hsCRP) concentration.(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of albumin concentration(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of total bilirubin (TBIL)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of kidney function biomarkers(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of thyroid hormones(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of iron binding capacity(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of electrolytes(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of estimated glomerular filtration rate(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of nutritional and metabolic biomarkers(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum metabolite profile by Elevated Global metabolome analysis (amine/phenol and acid channels CIL LC-MS profiling)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in gut microbiota diversity(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in gut microbiota relative abundance(From enrollment to the end of treatment at 6 months.)
研究者
研究点 (2)
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