Multiple SclerosisPhase 1NCT05539729
Vancomycin Study in Multiple Sclerosis (MS)
A Phase 1 study testing Vancomycin in people with Multiple Sclerosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2023to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
New York, New York, 10029
Susan E Filomena, BA, 212-241-3841, susan.filomena@mssm.edu
Abigail Hintermeister, MPA, 212-241-3391, abigail.hintermeister@mssm.edu
About this study
Official title: Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Vancomycin, Placebo
- Keywords
- gut microbiome, peripheral immune function, neuroinflammation, gut-brain axis
- Medical subject headings
- Multiple Sclerosis, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
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.
PlaceboDrug
Placebo created by the IDS and encapsulated in red coating to match the Study Drug.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Experimental | 125mg antibiotic taken 4 times daily by mouth Receives: Drug: Vancomycin |
| Placebo | Placebo comparator | Matching placebo taken 4 times daily by mouth Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in abundance of butyrate producing bacteria
Changes in abundance of butyrate producing bacteria from baseline treatment up to 6 weeks
Measured: Baseline up to 6 weeks
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.
Measured: Baseline up to 6 weeks
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.
Measured: Baseline up to 6 weeks
Secondary outcomes (14)
Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria
Changes in abundance of SCFA-producing bacteria
Measured: Baseline and 12 months
Change in stool SCFAs levels
Change in stool SCFAs levels
SCFAs are substance that are produce when gut bacteria breaks down food.
Measured: Baseline and 12 months
Change in serum SCFAs levels
Change in serum SCFAs levels
Measured: Baseline and 12 months
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.
Measured: Baseline and 12 months
Change in volume of gadolium enhancing brain lesions
Measured: Baseline and 12 months
Change in number of new brain lesions
Measured: Baseline and 12 months
Change in volume of new brain lesions
Measured: Baseline and 12 months
Change in number of total brain lesions
Measured: Baseline and 12 months
Change in volume of total brain lesions
Measured: Baseline and 12 months
Changes in number of paramagnetic rim lesions
Changes in number of paramagnetic rim lesions
Paramagnetic rim lesions are a type of brain injury found in MS patients.
Measured: Baseline and 12 months
Changes in volume of paramagnetic rim lesions
Changes in volume of paramagnetic rim lesions
Measured: Baseline and 12 months
Changes in thalamic brain volumes
Changes in thalamic brain volumes
Measured: Baseline and 12 months
Changes in cortical brain volumes
Changes in cortical brain volumes
Measured: Baseline and 12 months
Changes in total brain volumes
Changes in total brain volumes
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start31 Jan 2023
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled blinded trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Principal investigator, Stephanie K Tankou, Icahn School of Medicine at Mount Sinai
- Investigators
- Stephanie K Tankou, MD, Principal investigator, Icahn School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539729
- Sponsor's protocol ID
- GCO-22-0462
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2022
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigator is not developing the product. The study has been exempted from an IND by the FDA, since it entails the off-label use of a marketed drug.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05539729
- Acronym / sponsor ID
- GCO-22-0462
- Conditions
- Multiple Sclerosis
- Keywords
- gut microbiome, peripheral immune function, neuroinflammation, gut-brain axis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Placebo-controlled blinded trial
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Experimental | Drug: Vancomycin125mg antibiotic taken 4 times daily by mouth |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo taken 4 times daily by mouth |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinA 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. | Drug | Vancomycin |
| PlaceboPlacebo created by the IDS and encapsulated in red coating to match the Study Drug. | Drug | Placebo |
Primary outcome
Changes in abundance of butyrate producing bacteria
Time frame: Baseline up to 6 weeks
Changes in abundance of butyrate producing bacteria from baseline treatment up to 6 weeks
Changes in Serum Butyrate levels
Time frame: Baseline up to 6 weeks
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.
Changes in number of peripheral T cells
Time frame: Baseline up to 6 weeks
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.
14 secondary outcomes
Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria
Time frame: Baseline and 12 months
Change in stool SCFAs levels
Time frame: Baseline and 12 months
Change in serum SCFAs levels
Time frame: Baseline and 12 months
Change in number of gadolium enhancing brain lesions
Time frame: Baseline and 12 months
Change in volume of gadolium enhancing brain lesions
Time frame: Baseline and 12 months
Change in number of new brain lesions
Time frame: Baseline and 12 months
Change in volume of new brain lesions
Time frame: Baseline and 12 months
Change in number of total brain lesions
Time frame: Baseline and 12 months
Change in volume of total brain lesions
Time frame: Baseline and 12 months
Changes in number of paramagnetic rim lesions
Time frame: Baseline and 12 months
Changes in volume of paramagnetic rim lesions
Time frame: Baseline and 12 months
Changes in thalamic brain volumes
Time frame: Baseline and 12 months
Changes in cortical brain volumes
Time frame: Baseline and 12 months
Changes in total brain volumes
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No. The investigator is not developing the product. The study has been exempted from an IND by the FDA, since it entails the off-label use of a marketed drug.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie K Tankou, MD principal investigator
Icahn School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vancomycin in people with Multiple Sclerosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan E Filomena, BA (212-2413841, susan.filomena@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in abundance of butyrate producing bacteria (time frame: Baseline up to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.