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
|Condition or disease||Intervention/treatment||Phase|
|Progressive Multiple Sclerosis||Drug: Tauroursodeoxycholic Acid Drug: Placebo oral capsule||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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 :||February 2020|
|Estimated Study Completion Date :||May 2020|
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.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423121
|Contact: Jesse Ritter, MHSfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Jesse Ritter, MHS 410-502-2488 email@example.com|
|Principal Investigator:||Pavan Bhargava, MBBS, MD||Johns Hopkins University|