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
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Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Johns Hopkins University
Tracking Information | |||||
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First Submitted Date ICMJE | January 12, 2018 | ||||
First Posted Date ICMJE | February 6, 2018 | ||||
Last Update Posted Date | November 30, 2020 | ||||
Actual Study Start Date ICMJE | June 19, 2018 | ||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Treatment |
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Condition ICMJE | Progressive Multiple Sclerosis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 2021 | ||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Johns Hopkins University | ||||
Study Sponsor ICMJE | Johns Hopkins University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Johns Hopkins University | ||||
Verification Date | November 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |