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| Name | Class |
|---|---|
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Tang-Du Hospital | OTHER |
| The First Affiliated Hospital of Hainan Medical University | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taurine + DMTs | Experimental | Experimental group |
|
| DMTs | Placebo Comparator | control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMTs + taurine | Drug | DMTs + Taurine |
| |
| DMTs |
| Measure | Description | Time Frame |
|---|---|---|
| MRI leision activity | Change in the number, size, and volume of new or enlarging T2 and Gd-enhancing T1 lesions on brain and spinal MRI scans | From enrollment to the end of treatment at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| EDSS score | Change in Expanded Disability Status Scale (EDSS) score to assess disability progression or improvement | From enrollment to the end of treatment at 2 years |
| Annualized Relapse Rate (ARR) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome Measures | All adverse events occurring during the study period will be recorded, including their onset time, duration, severity, outcome, and relationship to the study drug (taurine). Serious adverse events will be reported immediately according to GCP requirements. | From enrollment to the end of treatment at 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cunjin Zhang, MD, PhD | Contact | 86-13645196561 | zhangcunjin516@163.com | |
| Li Zeng, MD, PhD | Contact | 86-17721863039 | 346004863@qq.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33686135 | Background | Tian J, Song M, Kaufman DL. Homotaurine limits the spreading of T cell autoreactivity within the CNS and ameliorates disease in a model of multiple sclerosis. Sci Rep. 2021 Mar 8;11(1):5402. doi: 10.1038/s41598-021-84751-3. |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D013654 | Taurine |
| ID | Term |
|---|---|
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
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| Lanzhou University Second Hospital |
| OTHER |
| First Affiliated Hospital of Kunming Medical University | OTHER |
| Daping Hospital of Army Medical University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Affiliated Hospital of North Sichuan Medical College | OTHER |
| Beijing Tiantan Hospital | OTHER |
| The People's Hospital of Leshan | OTHER |
| The Affiliated Hospital of Inner Mongolia Medical University | OTHER |
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| Drug |
DMTs |
|
Number of confirmed clinical relapses per patient-year during the 24-month treatment period
| From enrollment to the end of treatment at 2 years |
| Gut Microbiota Composition | Alterations in gut microbial diversity and relative abundance of key taxa analyzed by 16S rRNA sequencing of stool samples at baseline, Month 12, and Month 24 | From enrollment to the end of treatment at 2 years |
| Serum Biomarkers (GFAP and NfL) | Change in serum levels of glial fibrillary acidic protein (GFAP) and neurofilament light chain (NfL) from baseline to Month 24 as indicators of neuroinflammation and axonal injury. | From enrollment to the end of treatment at 2 years |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |