Health TrialsbyHealthPanel

Vancomycin Study in Multiple Sclerosis (MS)

ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vancomycin

    Drug

    A marketed antibiotic (Study Drug) supplied by Amerisource Bergen, by the Mount Sinai Investigational Drug Services (IDS), and encapsulated in red coating to match the placebo.

  • Placebo

    Drug

    Placebo created by the IDS and encapsulated in red coating to match the Study Drug.

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: VancomycinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in abundance of butyrate producing bacteria

Changes in abundance of butyrate producing bacteria from baseline treatment up to 6 weeks

Time frame
Baseline up to 6 weeks
2

Changes in Serum Butyrate levels

Changes in serum butyrate level from baseline treatment up to 6 weeks Butyrate is a substance that is produce when gut bacteria breaks down food. Butyrate can get into our blood circulation and regulate how our immune cells function.

Time frame
Baseline up to 6 weeks
3

Changes in number of peripheral T cells

Change in frequency of peripheral regulatory T cells baseline treatment up to 6 weeks. T cells are a type of lymphocyte. Lymphocytes are a type of white blood cell. They make up part of the immune system. T cells help the body fight diseases or harmful substances, such as bacteria or viruses.

Time frame
Baseline up to 6 weeks

Secondary outcomes

1

Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria

Changes in abundance of SCFA-producing bacteria

Time frame
Baseline and 12 months
2

Change in stool SCFAs levels

Change in stool SCFAs levels SCFAs are substance that are produce when gut bacteria breaks down food.

Time frame
Baseline and 12 months
3

Change in serum SCFAs levels

Change in serum SCFAs levels

Time frame
Baseline and 12 months
4

Change in number of gadolium enhancing brain lesions

Change in number gadolium enhancing brain lesions A lesion is a brain injury caused by inflammation. Gadolinium is a dye that is used to visualize areas of active inflammation in the brain.

Time frame
Baseline and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Doris Duke Charitable Foundation

Collaborator

Source ClinicalTrials.gov
Apply now