Back to resultsVancomycin Study in Multiple Sclerosis (MS)
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring gut microbiome, peripheral immune function, neuroinflammation, gut-brain axis
Eligibility 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.
Sites / Locations
- Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount SinaiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vancomycin
Placebo
Arm Description
125mg antibiotic taken 4 times daily by mouth
Matching placebo taken 4 times daily by mouth
Outcomes
Primary Outcome Measures
Changes in abundance of butyrate producing bacteria
Changes in abundance of butyrate producing bacteria from baseline treatment 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.
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.
Secondary Outcome Measures
Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria
Changes in abundance of SCFA-producing bacteria
Change in stool SCFAs levels
Change in stool SCFAs levels
SCFAs are substance that are produce when gut bacteria breaks down food.
Change in serum SCFAs levels
Change in serum SCFAs levels
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.
Change in volume of gadolium enhancing brain lesions
Change in number of new brain lesions
Change in volume of new brain lesions
Change in number of total brain lesions
Change in volume of total brain lesions
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.
Changes in volume of paramagnetic rim lesions
Changes in volume of paramagnetic rim lesions
Changes in thalamic brain volumes
Changes in thalamic brain volumes
Changes in cortical brain volumes
Changes in cortical brain volumes
Changes in total brain volumes
Changes in total brain volumes
Full Information
NCT ID
NCT05539729
First Posted
September 12, 2022
Last Updated
July 28, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Doris Duke Charitable Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05539729
Brief Title
Vancomycin Study in Multiple Sclerosis (MS)
Official Title
Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Doris Duke Charitable Foundation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
gut microbiome, peripheral immune function, neuroinflammation, gut-brain axis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Placebo-controlled blinded trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
The research team will be blinded to the treatment group (placebo/vancomycin).
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vancomycin
Arm Type
Experimental
Arm Description
125mg antibiotic taken 4 times daily by mouth
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo taken 4 times daily by mouth
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo created by the IDS and encapsulated in red coating to match the Study Drug.
Primary Outcome Measure Information:
Title
Changes in abundance of butyrate producing bacteria
Description
Changes in abundance of butyrate producing bacteria from baseline treatment up to 6 weeks
Time Frame
Baseline up to 6 weeks
Title
Changes in Serum Butyrate levels
Description
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
Title
Changes in number of peripheral T cells
Description
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 Outcome Measure Information:
Title
Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria
Description
Changes in abundance of SCFA-producing bacteria
Time Frame
Baseline and 12 months
Title
Change in stool SCFAs levels
Description
Change in stool SCFAs levels
SCFAs are substance that are produce when gut bacteria breaks down food.
Time Frame
Baseline and 12 months
Title
Change in serum SCFAs levels
Description
Change in serum SCFAs levels
Time Frame
Baseline and 12 months
Title
Change in number of gadolium enhancing brain lesions
Description
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
Title
Change in volume of gadolium enhancing brain lesions
Time Frame
Baseline and 12 months
Title
Change in number of new brain lesions
Time Frame
Baseline and 12 months
Title
Change in volume of new brain lesions
Time Frame
Baseline and 12 months
Title
Change in number of total brain lesions
Time Frame
Baseline and 12 months
Title
Change in volume of total brain lesions
Time Frame
Baseline and 12 months
Title
Changes in number of paramagnetic rim lesions
Description
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
Title
Changes in volume of paramagnetic rim lesions
Description
Changes in volume of paramagnetic rim lesions
Time Frame
Baseline and 12 months
Title
Changes in thalamic brain volumes
Description
Changes in thalamic brain volumes
Time Frame
Baseline and 12 months
Title
Changes in cortical brain volumes
Description
Changes in cortical brain volumes
Time Frame
Baseline and 12 months
Title
Changes in total brain volumes
Description
Changes in total brain volumes
Time Frame
Baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan E Filomena, BA
Phone
212-2413841
Email
susan.filomena@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail Hintermeister, BA, MPH
Phone
212-241-3391
Email
abigail.hintermeister@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie K Tankou, MD
Organizational Affiliation
Icahn School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan E Filomena, BA
Phone
212-241-3841
Email
susan.filomena@mssm.edu
First Name & Middle Initial & Last Name & Degree
Abigail Hintermeister, MPA
Phone
212-241-3391
Email
abigail.hintermeister@mssm.edu
First Name & Middle Initial & Last Name & Degree
Stephanie K Tankou
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Vancomycin Study in Multiple Sclerosis (MS)
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