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.
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
|Contact: Jesse Ritter, MHSemail@example.com|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Jesse Ritter, MHS 410-502-2488 firstname.lastname@example.org|
|Principal Investigator:||Pavan Bhargava, MBBS, MD||Johns Hopkins University|