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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
59
Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
Participants will be given four capsules of the placebo twice daily.
Johns Hopkins University
Baltimore, Maryland, United States
Number of Participants With at Least One Treatment-related Adverse Event
Safety and tolerability will be assessed based on treatment-related adverse events in the two arms.
Time frame: 16 weeks
Number of Total Treatment-related Adverse Events
Safety and tolerability will be assessed based on treatment-related adverse events in the two arms.
Time frame: 16 weeks
Incidence of Treatment-related Adverse Events (AE)
Safety and tolerability will be assessed based on treatment-related adverse events in the two arms. AE incidence will be measured as total number of events per 1000 exposure years.
Time frame: 16 weeks
Change in Fasting Bile Acid Levels in Plasma
The change of targeted bile acid levels over the course of 16 weeks (duration of the study) is reported. Bile acid levels (ng/mL) were log transformed before analysis to approximate normal distribution. Units are log(levels) per 16 weeks. Values are derived from linear mixed-effects models.
Time frame: Baseline to 16 weeks
Change in Microbiome Alpha-diversity Measured by Shannon Index at the End of the Study
Change in Shannon index of the gut microbiota between baseline and end of study (16 weeks). Shot-gun metagenomic sequencing in first morning stool specimen was utilized to derive the microbiome composition. Higher values of the index indicate more diversity in the microbial community. The minimum value the Shannon index can take is 0 (no diversity). There is no upper limit to the index.
Time frame: Baseline to 16 weeks
Change in Flow Cytometric Assessments of Peripheral Blood Mononuclear Cells (PBMCs)
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Change in flow cytometric assessments over the course of 16 weeks (duration of the study). Cells are expressed as ratios of their parent types. Units reported as change in the ratio per 16 weeks. Values are derived from linear mixed-effects models.
Time frame: Baseline to 16 weeks
Change in Quality of Life Based on Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument
Change in physical and mental health scores as assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54) instrument over the course of 16 weeks (duration of the study). This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. Two summary scores - physical health and mental health - are derived from a weighted combination of scale scores. Higher scores suggest a better quality of life. Scores can range from 0 to 100.
Time frame: Baseline to 16 weeks