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Vancomycin Study in Multiple Sclerosis (MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05539729
Recruitment Status : Recruiting
First Posted : September 14, 2022
Last Update Posted : November 22, 2022
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Stephanie K Tankou, Icahn School of Medicine at Mount Sinai

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Vancomycin Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo-controlled blinded trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The research team will be blinded to the treatment group (placebo/vancomycin).
Primary Purpose: Treatment
Official Title: Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis
Actual Study Start Date : November 8, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vancomycin
125mg antibiotic taken 4 times daily by mouth
Drug: Vancomycin
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 Comparator: Placebo
Matching placebo taken 4 times daily by mouth
Drug: Placebo
Placebo created by the IDS and encapsulated in red coating to match the Study Drug.




Primary Outcome Measures :
  1. 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

  2. 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.


  3. 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.



Secondary Outcome Measures :
  1. Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria [ Time Frame: Baseline and 12 months ]
    Changes in abundance of SCFA-producing bacteria

  2. Change in stool SCFAs levels [ Time Frame: Baseline and 12 months ]

    Change in stool SCFAs levels

    SCFAs are substance that are produce when gut bacteria breaks down food.


  3. Change in serum SCFAs levels [ Time Frame: Baseline and 12 months ]
    Change in serum SCFAs levels

  4. Change in number of gadolium enhancing brain lesions [ Time Frame: Baseline and 12 months ]

    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.


  5. Change in volume of gadolium enhancing brain lesions [ Time Frame: Baseline and 12 months ]
  6. Change in number of new brain lesions [ Time Frame: Baseline and 12 months ]
  7. Change in volume of new brain lesions [ Time Frame: Baseline and 12 months ]
  8. Change in number of total brain lesions [ Time Frame: Baseline and 12 months ]
  9. Change in volume of total brain lesions [ Time Frame: Baseline and 12 months ]
  10. Changes in number of paramagnetic rim lesions [ Time Frame: Baseline and 12 months ]

    Changes in number of paramagnetic rim lesions

    Paramagnetic rim lesions are a type of brain injury found in MS patients.


  11. Changes in volume of paramagnetic rim lesions [ Time Frame: Baseline and 12 months ]
    Changes in volume of paramagnetic rim lesions

  12. Changes in thalamic brain volumes [ Time Frame: Baseline and 12 months ]
    Changes in thalamic brain volumes

  13. Changes in cortical brain volumes [ Time Frame: Baseline and 12 months ]
    Changes in cortical brain volumes

  14. Changes in total brain volumes [ Time Frame: Baseline and 12 months ]
    Changes in total brain volumes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed ((symptoms onset less than 6 months ago),
  • treatment naive MS patients
  • aged 18 - 45
  • who intend to use a disease-modifying therapy to treat multiple sclerosis.

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. Patients are screened clinically for hepatitis B and C, and HIV, before MS treatment selection;
  • Pregnancy or less than 6 months postpartum;
  • Irritable bowel syndrome and other bowel dysfunction such as constipation; or 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05539729


Contacts
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Contact: Susan E Filomena, BA 212-2413841 susan.filomena@mssm.edu
Contact: Abigail Hintermeister, BA, MPH 212-241-3391 abigail.hintermeister@mssm.edu

Locations
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United States, New York
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Susan E Filomena, BA    212-241-3841    susan.filomena@mssm.edu   
Contact: Abigail Hintermeister, MPA    212-241-3391    abigail.hintermeister@mssm.edu   
Principal Investigator: Stephanie K Tankou         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Doris Duke Charitable Foundation
Investigators
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Principal Investigator: Stephanie K Tankou, MD Icahn School of Medicine
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Responsible Party: Stephanie K Tankou, Assistant Professor, Neurology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT05539729    
Other Study ID Numbers: GCO-22-0462
First Posted: September 14, 2022    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Stephanie K Tankou, Icahn School of Medicine at Mount Sinai:
gut microbiome
peripheral immune function
neuroinflammation
gut-brain axis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents