RightFit
RecruitingPhase 1

Vancomycin Study in Multiple Sclerosis (MS)

Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Hence, here the research team proposes to investigate the effects of vancomycin on the gut microbiota composition, peripheral immune function, and brain MRI lesions in MS patients."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how vancomycin changes gut microbes, the immune system, and areas of brain damage seen on MRI scans. It is for adults ages 18–50 with newly diagnosed MS or early signs of MS who have not started treatment.

The overall goal of this study is to elucidate a mechanism by which vancomycin modulates the gut-brain axis in multiple sclerosis (MS). The gut microbiome plays an important role in autoimmunity, including MS. However, the identity of gut microbes modulating neuroinflammation in MS and their mechanisms of action remain obscure. Hence, here the research team proposes to investigate the effects of vancomycin on the gut microbiota composition, peripheral immune function, and brain MRI lesions in MS patients.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–50 years old.
  • You have newly diagnosed MS under the 2017 McDonald rules, CIS (a first episode of MS-like symptoms), or RIS (MS-like changes on a scan). Any symptoms started within the past year.
  • You have not started treatment for your condition.
  • You can understand the study’s risks, benefits, and other choices, and agree to take part.

Who can't join

  • You used antibiotics in the past 90 days, or prebiotics, probiotics, steroid medicines, or tobacco in the past month.
  • You have ever taken medicines that weaken the immune system.
  • You had a stomach or bowel infection in the past month, or have a long-term infection such as hepatitis B, hepatitis C, or HIV.
  • You are pregnant or gave birth less than 6 months ago.
  • You have irritable bowel syndrome, constipation or other bowel problems, past bowel surgery, or an eating disorder such as anorexia, bulimia, or binge eating.
  • You have inflammatory bowel disease, rheumatoid arthritis, lupus, diabetes, or another autoimmune illness, where the immune system attacks the body. You have another brain, nerve, behavior, or mental health condition that makes taking part unsafe or unlikely to succeed.
  • You traveled outside the country in the past month.
  • You cannot safely take vancomycin because of low kidney function (eGFR below 60), hearing problems, or an allergy. You cannot safely have an MRI, for example because of metal objects implanted in your body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

NY