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NCT Number: NCT07263607

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

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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Key information

Conditions

Multiple Sclerosis (MS) Relapsing Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

DMTs + taurine

Drug

DMTs + Taurine

DMTs

Drug

DMTs

Primary outcomes

  1. MRI leision activity

    Time frame: 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

Secondary outcomes

  1. EDSS score

    Time frame: From enrollment to the end of treatment at 2 years

    Change in Expanded Disability Status Scale (EDSS) score to assess disability progression or improvement

  2. Annualized Relapse Rate (ARR)

    Time frame: From enrollment to the end of treatment at 2 years

    Number of confirmed clinical relapses per patient-year during the 24-month treatment period

  3. Gut Microbiota Composition

    Time frame: From enrollment to the end of treatment at 2 years

    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

  4. Serum Biomarkers (GFAP and NfL)

    Time frame: From enrollment to the end of treatment at 2 years

    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.

Other outcomes

  1. Safety Outcome Measures

    Time frame: From enrollment to the end of treatment at 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cunjin Zhang, MD, PhD

CONTACT

[email protected]

86-13645196561

Li Zeng, MD, PhD

CONTACT

[email protected]

86-17721863039

Sponsors and collaborators

Lead sponsor

Sichuan Academy of Medical Sciences

Other

Collaborators

  • Affiliated Hospital of North Sichuan Medical College
  • Beijing Tiantan Hospital
  • Daping Hospital of Army Medical University
  • First Affiliated Hospital of Chongqing Medical University
  • First Affiliated Hospital of Kunming Medical University
  • Lanzhou University Second Hospital
  • Shandong Provincial Hospital
  • Tang-Du Hospital
  • The Affiliated Hospital of Inner Mongolia Medical University
  • The First Affiliated Hospital of Hainan Medical University
  • The People's Hospital of Leshan

Registry information

Official study title

A Multicenter Clinical Study on Taurine Treatment for Multiple Sclerosis

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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