Status:
COMPLETED
A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis
Lead Sponsor:
Johns Hopkins University
Conditions:
Progressive Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2022
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03423121
Start Date
June 19 2018
End Date
July 5 2022
Last Update
May 3 2023
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287