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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 : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE January 12, 2018
First Posted Date  ICMJE February 6, 2018
Last Update Posted Date August 7, 2018
Actual Study Start Date  ICMJE June 19, 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03423121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
  • Metabolomics [ Time Frame: Baseline to 16 weeks ]
    Change in fasting bile acid levels in plasma.
  • 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.
  • Immunophenotyping [ Time Frame: Baseline to 16 weeks ]
    Change in flow cytometric assessments of peripheral blood mononuclear cells.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis
Official Title  ICMJE A Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Progressive Multiple Sclerosis
Intervention  ICMJE
  • Drug: Tauroursodeoxycholic Acid
    Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
    Other Name: Taurolite
  • Drug: Placebo oral capsule
    Participants will be given four capsules of the placebo twice daily.
Study Arms  ICMJE
  • Experimental: TUDCA Treatment
    Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
    Intervention: Drug: Tauroursodeoxycholic Acid
  • Placebo Comparator: Placebo oral capsule
    Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jesse Ritter, MHS 410-502-2488 jritte15@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03423121
Other Study ID Numbers  ICMJE IRB00144766
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pavan Bhargava, MBBS, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP