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A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis

A Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS Patients

NCT03423121•Johns Hopkins University

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

Age

18 - No limit years

Sex

ALL

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

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States

Key Dates

Start Date

June 19, 2018

Primary Completion Date

April 28, 2022

Completion Date

July 5, 2022

Last Updated

May 3, 2023

Enrollment

ACTUAL participants

Conditions

Progressive Multiple Sclerosis

Interventions

Tauroursodeoxycholic Acid

DRUG

Placebo oral capsule

DRUG

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Secondary Progressive Multiple Sclerosis (SPMS)

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RECRUITING

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Multiple SclerosisRemitting-Relapsing Multiple Sclerosis+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis

Inclusion Criteria

Exclusion Criteria

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