A Phase 1 interventional study of Vancomycin and Placebo in Multiple Sclerosis, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 1, Interventional, and Treatment
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Among 1,192 studies in Multiple Sclerosis with a site in United States — 184 open to participants now, 259 under way, 23 of them phase 3. Multiple Sclerosis · United States.
Among the 1,192 studies in Multiple Sclerosis with a site in United States, this one is the 759th largest by planned enrollment of the 879 interventional ones that give a count, is one of 69 that started in 2023, is one of 105 in phase 1, reaches primary completion later than 175 of the 256 other live ones, and was the 953rd registered.
3,269 studies on the registry are indexed under Multiple Sclerosis; 663 are open to participants now.
Browse Multiple Sclerosis studies →184 of the 1,192 studies in Multiple Sclerosis with a site in United States are open now. Recruiting first, the newest first:
Sundance Biosciences, Inc. · Sites in United States
Ages 18–70
Genentech, Inc. · Sites in United States, Puerto Rico
Ages 18–65
The University of Texas Health Science Center, Houston · Sites in United States
Ages 18+
Washington University School of Medicine · Sites in United States
Ages 40–70
University of Texas at Austin · Sites in United States
Ages 18–80
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 431 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 212 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,192 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 142 · Phase 2 191 · Phase 3 142 · Phase 4 82
First in 1976; this study’s year is marked. 69 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 12 is below the median of 50 across 2,205 interventional studies indexed under Multiple Sclerosis.
Median enrollment 50 across the 879 interventional studies, 100 across the 302 observational. Of the 818 that completed or were terminated, 332 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
376 of 1,192 have an industry lead sponsor. The 10 most frequent:
Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Icahn School of Medicine at Mount Sinai has 7 studies filed under Multiple Sclerosis — fewer than ten, so there is no comparison to draw.
78 of the studies in Multiple Sclerosis with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05134441Phase 3Immunic AGStudy to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis | 2026-11 |
| NCT05877963Phase 3TG Therapeutics, Inc.Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab | 2027-01-21 |
| NCT06136728Phase 3MGH Institute of Health ProfessionsDalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis | 2027-05 |
| NCT06141473Phase 3SanofiEfficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | 2027-05-06 |
| NCT07325292Phase 3SanofiNon-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis | 2027-07-15 |
Add all 78 to your calendar (.ics) → With an account.
Among the 1,192 studies in Multiple Sclerosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
125mg antibiotic taken 4 times daily by mouth
Drug: Vancomycin
Matching placebo taken 4 times daily by mouth
Drug: Placebo
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 created by the IDS and encapsulated in red coating to match the Study Drug.
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
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
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
Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria
Changes in abundance of SCFA-producing bacteria
Time frame: 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.
Time frame: Baseline and 12 months
Change in serum SCFAs levels
Change in serum SCFAs levels
Time frame: 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.
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
Changes in number of paramagnetic rim lesions Paramagnetic rim lesions are a type of brain injury found in MS patients.
Time frame: Baseline and 12 months
Changes in volume of paramagnetic rim lesions
Changes in volume of paramagnetic rim lesions
Time frame: Baseline and 12 months
Changes in thalamic brain volumes
Changes in thalamic brain volumes
Time frame: Baseline and 12 months
Changes in cortical brain volumes
Changes in cortical brain volumes
Time frame: Baseline and 12 months
Changes in total brain volumes
Changes in total brain volumes
Time frame: Baseline and 12 months
Plan to share: 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.
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Jun 2028, 65 months after the start.
Of 53 non-industry phase 1 interventional studies under Multiple Sclerosis, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 71. This study's planned 65 months is above that.
Counting every sponsor, half of 92 studies reached it within 30 months; a quarter within 9 and three quarters within 56.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 28, 2026: primary completion Mar 2026 → Jun 2028 and completion Sep 2026 → Dec 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Vancomycin
Icahn School of Medicine at Mount Sinai →