NCT05622526尚未招募2 期
Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Fecal Microbiota Transfer by Capsules vs. Placebo for the Treatment of Patients With Nonalcoholic Steatohepatitis
Instituto de Investigación Marqués de Valdecilla0 个研究点目标入组 96 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 主要终点
- Proportion of patients with improvement of fat fraction by proton density by MRI and no worsening of activity or fibrosis.
研究概览
简要总结
The EMOTION study is a multicentric, double-blind, controlled, parallel-group, phase IIa randomized Clinical trial to evaluate the efficacy, safety and tolerability of TMF capsules for the treatment of patients with NASH.
The clinical trial has two stages:
- Screening phase with a duration of 12 weeks to classify patients based on lifestyle modifications.
- Treatment phase where patients will be randomized and stratified 2:1 to treatment:
- Experimental for n=64 patients.
- Placebo control for n=32 patients.
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
- Double (Participant, Investigator)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders aged between 18 and75 years old (both included).
- •Body mass index (BMI) <40 kg/m
- •Histological diagnosis of NASH, accepted by EASL and AASLD , from a liver biopsy obtained up to 24 weeks prior to the signing of the informed consent.
- •NASH histologic activity score (NAS) ≥ 4, with a score of 1 or more in each subcomponent (steatosis, lobular inflammation, and liver cell ballooning).
- •Histologic evidence of stage 1 fibrosis (with perisinusoidal or portal fibrosis), stage 2 (perisinusoidal and portal/periportal fibrosis), or stage 3 (bridging fibrosis) as defined by the NASH CRN fibrosis score.
排除标准
- •Evidence of other type of liver disease.
- •History of high alcohol intake (daily consumption > 30 g/day for men and > 20 g/day for women).
- •Weight change of more than 5% in the 3 months prior to screening.
- •Subjects with HbA1c> 9.5%. For subjects with an HbA1c> 9.5% at the screening visit, a repeat test may be performed within the screening window.
- •A repeated result of HbA1c> 9.5% will result in exclusion.
- •Diabetic patients with:
- •Insulin treatment.
- •Changes in antidiabetic medication in the 4 months prior to liver biopsy according to the following conditions:
- •Modification of the dose of treatment with glucagon agonists type 1 (GLP-1).
- •Implementation of treatment with a new antidiabetic.
- •History of bariatric surgery.
- •Portal thrombosis.
- •Known or suspected hepatocellular carcinoma.
- •Clinically significant gastrointestinal, cardiovascular, neurological, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease, as determined by the investigator.
- •An estimated glomerular filtration rate (eGFR) <45 ml / min / 1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] method).
- •Medical conditions that decrease life expectancy to less than 2 years, including cancer.
- •Presence of an inherited or acquired immunodeficiency.
- •Diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis, microscopic colitis), active irritable bowel syndrome (within the last 2 years according to Rome IV criteria), celiac disease not well controlled with a gluten-free diet, active gastroparesis, toxic megacolon.
- •Major intra-abdominal surgery in the 2 months prior to randomization of the patient in the study.
- •Antibiotic intake in the 8 weeks prior to the screening date.
- •Probiotic/prebiotic/marketed synbiotic intake in the 4 weeks prior to the screening date.
- •Pregnancy or lactation.
- •Any other condition that, in the opinion of the investigator, could prevent or hinder compliance.
- •Use of medication with potential steatogenic effect (corticosteroids, valproic acid, amiodarone and/or tamoxifen) within the 6 months prior to the first dose of study drug.
研究组 & 干预措施
Group 1 or Experimental group
Experimental
treatment with an initial dose of 24 oral capsules of MBK-01 and a maintenance dose of 12 oral capsules of MBK-01 every 3 months (4 maintenance doses).
干预措施: Group 1 or Experimental group (Drug)
Group 2 or Control group
Placebo Comparator
treatment with an initial dose of 24 oral capsules of MBK-01 and a maintenance dose of 12 oral capsules of MBK-01 every 3 months for 12 months (4 maintenance doses)
干预措施: Group 2 or Control group (Other)
结局指标
主要结局
Proportion of patients with improvement of fat fraction by proton density by MRI and no worsening of activity or fibrosis.
时间窗: 72 weeks
number of adverse events (AEs), serious AEs, AEs resulting in discontinuation of study treatment, AEs of special interest, and changes in vital signs and laboratory values
时间窗: 72 weeks
次要结局
- Proportion of patients with improvement (at least one point) in lobular swelling and/or ballooning without worsening of fibrosis.(72 weeks)
- NAFLD Fibrosis score(72 weeks)
- Changes in systolic and diastolic blood pressure, lipid profile, carotid ultrasound.(72 weeks)
- Changes in weight, BMI.(72 weeks)
- Changes in the quality of life questionnaire specific to chronic liver disease due to NAFLD.(72 weeks)
- patient-reported outcomes(72 weeks)
研究者
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