Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
More Inclusion & Exclusion 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Johns Hopkins University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Pavan Bhargava, MBBS, MD|
|Principal Investigator Affiliation||Johns Hopkins University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Progressive Multiple Sclerosis|
Arms & Interventions
Experimental: TUDCA Treatment
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Placebo Comparator: Placebo oral capsule
Placebo oral capsule 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.
Drug: - Placebo oral capsule
Participants will be given four capsules of the placebo twice daily.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.