Multiple Sclerosis Clinical Trial
A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis
Summary
This study aims to identify the safety and tolerability of bile acid supplementation in patients with progressive Multiple Sclerosis (MS). Participants will also be assessed for an impact of the bile acid on their immune system and gut microbiome. Half of the participants will receive the bile acid tauroursodeoxycholic acid (TUDCA) and half will receive placebo. The investigators believe participants who take TUDCA will have normalization of blood bile acid levels, a normalization of abnormal immune response and a normalization of the gut microbiome.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Progressive MS based on Lublin Criteria
Low bile acid levels identified using targeted metabolomics analysis
On the same therapy for the past 6 months and not expected to switch therapy in the next 6 months
No relapse in the past 3 months
Exclusion Criteria:
No previous history of liver disease or cholecystectomy
No stage IV/V chronic kidney disease or other severe metabolic derangements (e.g. poorly controlled thyroid disease or diabetes)
BMI < 15 kg/m2 and BMI > 40 kg/m2
Female patients who are pregnant or nursing, or not willing to use contraception
Chronic antibiotic use
Corticosteroid treatment within the past 30 days
Known history of other neuroinflammatory, neurodegenerative or systemic autoimmune disease
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There is 1 Location for this study
Baltimore Maryland, 21287, United States
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