A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Taurursodiol
Unknown
Placebo or sham
- Placebo oral capsule
Results by group
Number of Participants With at Least One Treatment-related Adverse Event
16 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| TUDCA Treatment | 10 Participants | 26 | |
| Placebo Oral Capsule | 7 Participants | 21 |
TUDCA Treatment
Placebo Oral Capsule
Number of Total Treatment-related Adverse Events
16 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| TUDCA Treatment | 11 total treatment-related adverse events | 26 | |
| Placebo Oral Capsule | 8 total treatment-related adverse events | 21 |
TUDCA Treatment
Placebo Oral Capsule
Incidence of Treatment-related Adverse Events (AE)
16 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| TUDCA Treatment | 1218 total events per 1000 exposure years | 26 | |
| Placebo Oral Capsule | 1061 total events per 1000 exposure years | 21 |
TUDCA Treatment
Placebo Oral Capsule
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| TUDCA Treatment | 26 | 1 (3.8%) | 0 |
| Placebo Oral Capsule | 21 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants With at Least One Treatment-related Adverse Event
16 weeks
SafetyNumber of Total Treatment-related Adverse Events
16 weeks
SafetyIncidence of Treatment-related Adverse Events (AE)
16 weeks
Safety
Other measures (4)
Change in Fasting Bile Acid Levels in Plasma
Baseline to 16 weeks
Change in Microbiome Alpha-diversity Measured by Shannon Index at the End of the Study
Baseline to 16 weeks
Change in Flow Cytometric Assessments of Peripheral Blood Mononuclear Cells (PBMCs)
Baseline to 16 weeks
Change in Quality of Life Based on Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument
Baseline to 16 weeks
Quality of life (reported by participants)
Who could take part
Progressive MS · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Jun 2018
Main results due
Apr 2022
Finished
Jul 2022
Results posted
May 2023
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