A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis

Johns Hopkins University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Progressive Multiple Sclerosis

Treatments

Drug: Placebo oral capsule

Drug: Tauroursodeoxycholic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT03423121

IRB00144766

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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