Vancomycin Study in Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

Official title:

Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05539729
• Other study ID #: GCO-22-0462
• Status: Recruiting
• Phase: Phase 1
• Start date: February 8, 2023
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Susan E Filomena, BA
• Phone: 212-2413841
• Email: susan.filomena[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Doris Duke Charitable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in abundance of butyrate producing bacteria	Changes in abundance of butyrate producing bacteria from baseline treatment up to 6 weeks	Baseline up to 6 weeks
Primary	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.	Baseline up to 6 weeks
Primary	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.	Baseline up to 6 weeks
Secondary	Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria	Changes in abundance of SCFA-producing bacteria	Baseline and 12 months
Secondary	Change in stool SCFAs levels	Change in stool SCFAs levels; SCFAs are substance that are produce when gut bacteria breaks down food.	Baseline and 12 months
Secondary	Change in serum SCFAs levels	Change in serum SCFAs levels	Baseline and 12 months
Secondary	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.	Baseline and 12 months
Secondary	Change in volume of gadolium enhancing brain lesions		Baseline and 12 months
Secondary	Change in number of new brain lesions		Baseline and 12 months
Secondary	Change in volume of new brain lesions		Baseline and 12 months
Secondary	Change in number of total brain lesions		Baseline and 12 months
Secondary	Change in volume of total brain lesions		Baseline and 12 months
Secondary	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.	Baseline and 12 months
Secondary	Changes in volume of paramagnetic rim lesions	Changes in volume of paramagnetic rim lesions	Baseline and 12 months
Secondary	Changes in thalamic brain volumes	Changes in thalamic brain volumes	Baseline and 12 months
Secondary	Changes in cortical brain volumes	Changes in cortical brain volumes	Baseline and 12 months
Secondary	Changes in total brain volumes	Changes in total brain volumes	Baseline and 12 months