A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis
NCT ID: NCT03423121
Last Updated: 2023-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
59 participants
INTERVENTIONAL
2018-06-19
2022-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TUDCA Treatment
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Tauroursodeoxycholic Acid
Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
Placebo oral capsule
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Placebo oral capsule
Participants will be given four capsules of the placebo twice daily.
Interventions
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Tauroursodeoxycholic Acid
Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
Placebo oral capsule
Participants will be given four capsules of the placebo twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Pavan Bhargava, MBBS, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB00144766
Identifier Type: -
Identifier Source: org_study_id
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