Investigating vancomycin's effects on multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore how vancomycin influences the gut-brain axis in patients with multiple sclerosis (MS). It will assess the impact of vancomycin on gut microbiota composition, peripheral immune function, and brain MRI lesions in newly diagnosed MS patients. By understanding these mechanisms, the research seeks to clarify the role of gut microbes in neuroinflammation associated with MS. Participants will be randomly assigned to receive either vancomycin or a placebo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* aged 18 - 50
* newly diagnosed MS (2017 McDonald criteria), CIS or RIS patients, who have experienced symptoms no earlier than the past year
* treatment naive
* able to understand the risks, benefits, and alternatives of participation and give meaningful consent

Exclusion Criteria:

* antibiotic use within the past 90 days;
* pre- or probiotic use within past month or corticosteroids use within the past month;
* use of tobacco products within the past 1 month;
* history of treatment with immunosuppressants;
* history of gastroenteritis within the past month or diagnosis with a chronic infectious disease, i.e. hepatitis B, C or HIV;
* pregnancy or less than 6 months postpartum;
* irritable bowel syndrome and other bowel dysfunction such as constipation;
* history of bowel surgery;
* inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes and any other auto-immune illness;
* diagnosis with another neurological disease, behavioral or psychiatric conditions that would be incompatible with a safe and successful participation in the study (such as severe major depression, schizophrenia and presence of psychotic symptoms);
* eating disorders such as anorexia nervosa, bulimia, or binge eating syndrome;
* travel outside of the country within the past month;
* contraindication to vancomycin including estimated glomerular filtration rate of \<60ml/min, impaired hearing or known allergy.
* Contraindication to MRI such as implanted metallic objects

Where it's running

• Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Stephanie K Tankou, MD — Icahn School of Medicine
• Study coordinator: Susan E Filomena, BA
• Email: susan.filomena@mssm.edu
• Phone: 212-2413841

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treadmill-based virtual reality walking training for MS patients

  This study tests whether a treadmill with virtual reality and smart socks can help people with multiple sclerosis walk better and feel safer in daily life.

  Recruiting Shepherd Center, Atlanta GA · Atlanta, Georgia · NCT07927439

• Virtual Reality and Mental Practice to Improve Balance and Walking in Relapsing MS

  This study tests whether virtual reality training or mental practice can improve balance and walking in people with relapsing–remitting multiple sclerosis.

  Recruiting Cairo University · Giza, Giza Governorate · NCT07918339

• REAL-MS: A Look at Autologous Stem Cell Transplant vs High-Efficacy MS Therapies in Real-World Care

  This study tests how AHSCT compares to high-efficacy MS medicines in adults treated in routine clinical care.

  Recruiting Imperial College London · London and 2 other locations · NCT07899502

• Tolebrutinib in real-world MS care for patients treated by clinicians

  This real-world study sees how tolebrutinib is used for multiple sclerosis patients and what outcomes look like in everyday practice.

  Recruiting Sanofi · Marina, Abu Dhabi Emirate · NCT07898371

• Pilates via live video vs. prerecorded videos for people with multiple sclerosis

  This study tests whether live, coach-led Pilates sessions through video calls are more beneficial than prerecorded Pilates videos for adults with MS.

  Recruiting Yuzuncu Yil University · Van · NCT07893925

• Cooling During Inpatient Rehab for People with MS

  This trial tests whether wearing a cooling vest during intensive training can reduce fatigue and improve walking, strength, balance, and cognition in people with multiple sclerosis during a 3-week inpatient rehab stay.

  Recruiting Klinik Valens · Valens, Canton of St. Gallen · NCT07852156

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.