Clinical trial NCT05539729: Vancomycin Study in Multiple Sclerosis (MS)
Official title: Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: gut microbiome
peripheral immune function
neuroinflammation
gut-brain axis
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2022-09-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo-controlled blinded trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in abundance of butyrate producing bacteria
timeFrame: Baseline up to 6 weeks
measure: Changes in Serum Butyrate levels
timeFrame: Baseline up to 6 weeks
measure: Changes in number of peripheral T cells
timeFrame: Baseline up to 6 weeks
Secondary outcomes:
measure: Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria
timeFrame: Baseline and 12 months
measure: Change in stool SCFAs levels
timeFrame: Baseline and 12 months
measure: Change in serum SCFAs levels
timeFrame: Baseline and 12 months
measure: Change in number of gadolium enhancing brain lesions
timeFrame: Baseline and 12 months
measure: Change in volume of gadolium enhancing brain lesions
timeFrame: Baseline and 12 months
measure: Change in number of new brain lesions
timeFrame: Baseline and 12 months
measure: Change in volume of new brain lesions
timeFrame: Baseline and 12 months
measure: Change in number of total brain lesions
timeFrame: Baseline and 12 months
measure: Change in volume of total brain lesions
timeFrame: Baseline and 12 months
measure: Changes in number of paramagnetic rim lesions
timeFrame: Baseline and 12 months
measure: Changes in volume of paramagnetic rim lesions
timeFrame: Baseline and 12 months
measure: Changes in thalamic brain volumes
timeFrame: Baseline and 12 months
measure: Changes in cortical brain volumes
timeFrame: Baseline and 12 months
measure: Changes in total brain volumes
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine
name: Stephanie K Tankou, MD
role: PRINCIPAL_INVESTIGATOR
References: