A Multicenter Clinical Study on Taurine Treatment for Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- MRI leision activity
研究概览
简要总结
This multicenter, randomized, open-label clinical trial aims to evaluate the efficacy and safety of taurine as an adjunctive therapy to standard disease-modifying treatments (DMTs) in patients with multiple sclerosis (MS). The study seeks to determine whether oral taurine can reduce the number and volume of new or enlarging MRI lesions, decrease relapse rates, and slow disability progression as measured by the Expanded Disability Status Scale (EDSS). It will also explore the effects of taurine on gut microbiota composition, serum neurodegeneration biomarkers (GFAP and NfL), and cognitive function assessed by MMSE and MoCA. Approximately 80 eligible participants will be enrolled and randomly assigned to either continue standard DMT therapy or receive taurine supplementation in addition to DMTs. The treatment duration will be 24 months, with follow-up visits every 3 months for clinical assessment, blood and stool sample collection, and MRI scans every 6 months. This study aims to provide new clinical evidence supporting taurine as a safe and potentially beneficial adjunctive therapy for multiple sclerosis.
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
- None
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
- •1.Age and Gender: Male or female participants aged 18 to 65 years.
- •2.Diagnosis: Patients diagnosed with multiple sclerosis (MS) according to the 2017 revised McDonald criteria.
- •3.Treatment Background: Patients receiving stable disease-modifying therapy (DMT) prior to enrollment.
- •4. EDSS score between 1.0 and 5.5 at screening.
- •5. Compliance: Ability and willingness to comply with all study procedures, follow-up visits, and study medication requirements.
- •6.Informed Consent: Participants must provide written informed consent before any study-specific procedures are performed.
- •7 Female participants must be non-pregnant and non-lactating, or, if of childbearing potential, must agree to use effective contraception during the study
排除标准
- •1. Patients with known hypersensitivity to taurine or any of its components
- •2. Women who are pregnant or breastfeeding
- •3. Patients currently participating in other clinical trials
- •4. Patients who refuse to participate in the relevant clinical study
研究组 & 干预措施
Taurine + DMTs
Experimental group
干预措施: DMTs + taurine (Drug)
DMTs
control
干预措施: DMTs (Drug)
结局指标
主要结局
MRI leision activity
时间窗: From enrollment to the end of treatment at 2 years
Change in the number, size, and volume of new or enlarging T2 and Gd-enhancing T1 lesions on brain and spinal MRI scans
次要结局
- EDSS score(From enrollment to the end of treatment at 2 years)
- Annualized Relapse Rate (ARR)(From enrollment to the end of treatment at 2 years)
- Gut Microbiota Composition(From enrollment to the end of treatment at 2 years)
- Serum Biomarkers (GFAP and NfL)(From enrollment to the end of treatment at 2 years)