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A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03423121
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Progressive Multiple Sclerosis Drug: Tauroursodeoxycholic Acid Drug: Placebo oral capsule Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS Patients
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TUDCA Treatment
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
 Drug: Tauroursodeoxycholic Acid
Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
Other Name: Taurolite
Placebo Comparator: Placebo oral capsule
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
 Drug: Placebo oral capsule
Participants will be given four capsules of the placebo twice daily.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-related adverse events [ Time Frame: 16 weeks ]
    Safety and tolerability will be assessed based on treatment-related adverse events in the two arms


Secondary Outcome Measures :
  1. Metabolomics [ Time Frame: Baseline to 16 weeks ]
    Change in fasting bile acid levels in plasma.

  2. Gut microbiota [ Time Frame: Baseline to 16 weeks ]
    Change in composition of the gut microbiota assessed using shot-gun metagenomic sequencing in first morning stool specimen.

  3. Immunophenotyping [ Time Frame: Baseline to 16 weeks ]
    Change in flow cytometric assessments of peripheral blood mononuclear cells.

  4. Quality of Life [ 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. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423121


Contacts
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Contact: Jesse Ritter, MHS 410-502-2488 jritte15@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jesse Ritter, MHS    410-502-2488    jritte15@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Pavan Bhargava, MBBS, MD Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03423121    
Other Study ID Numbers: IRB00144766
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Tauroursodeoxycholic acid
Antiviral Agents
Anti-Infective Agents
Cholagogues and Choleretics
Gastrointestinal Agents