A Multicenter Clinical Trial Evaluating the Efficacy and Safety of Taurine as an Adjunctive Therapy in Multiple Sclerosis

Summary

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.

Conditions

• Multiple Sclerosis (MS) Relapsing Remitting

Interventions

DRUG

DMTs + taurine

DMTs + Taurine

DRUG

DMTs

DMTs

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• The First Affiliated Hospital of Hainan Medical College

  collaborator UNKNOWN

• Lanzhou University Second Hospital

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Daping Hospital of Army Medical University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Affiliated Hospital of North Sichuan Medical College

  collaborator OTHER

• Beijing Tiantan Hospital

  collaborator OTHER

• The People's Hospital of Leshan

  collaborator OTHER

• The Affiliated Hospital of Inner Mongolia Medical University

  collaborator OTHER

• Sichuan Academy of Medical Sciences

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2029-07-31

Completion

2029-11-30