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Completed

NCT Number: NCT03423121

A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis

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.

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Key information

Conditions

Progressive Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tauroursodeoxycholic acid

Drug

Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.

Other names: Taurolite

Placebo oral capsule

Drug

Participants will be given four capsules of the placebo twice daily.

Primary outcomes

  1. Number of Participants With at Least One Treatment-related Adverse Event

    Time frame: 16 weeks

    Safety and tolerability will be assessed based on treatment-related adverse events in the two arms.

  2. Number of Total Treatment-related Adverse Events

    Time frame: 16 weeks

    Safety and tolerability will be assessed based on treatment-related adverse events in the two arms.

  3. Incidence of Treatment-related Adverse Events (AE)

    Time frame: 16 weeks

    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.

Secondary outcomes

  1. Change in Fasting Bile Acid Levels in Plasma

    Time frame: Baseline to 16 weeks

    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.

  2. Change in Microbiome Alpha-diversity Measured by Shannon Index at the End of the Study

    Time frame: Baseline to 16 weeks

    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.

  3. Change in Flow Cytometric Assessments of Peripheral Blood Mononuclear Cells (PBMCs)

    Time frame: Baseline to 16 weeks

    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.

  4. Change in Quality of Life Based on Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument

    Time frame: Baseline to 16 weeks

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

A Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS Patients

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2018
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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