A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/9/2018 |
| Start Date: | June 19, 2018 |
| End Date: | May 2020 |
| Contact: | Jesse Ritter, MHS |
| Email: | jritte15@jhmi.edu |
| Phone: | 410-502-2488 |
A Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS Patients
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.
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.
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
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Phone: 410-502-2488
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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