A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Taurochenodeoxycholic Acid; Tauroursodeoxycholic acid; Ursodoxicoltaurine

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