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Tauroursodeoxycholic Acid for Multiple Sclerosis

Phase 1 & 2
Waitlist Available
Led By Pavan Bhargava, MBBS, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial will test the safety and tolerability of bile acid supplements in people with progressive MS. It will also look at whether the supplements have an impact on participants' immune system and gut microbiome.

Eligible Conditions
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-related Adverse Events (AE)
Number of Participants With at Least One Treatment-related Adverse Event
Number of Total Treatment-related Adverse Events
Secondary outcome measures
Change in Fasting Bile Acid Levels in Plasma
Change in Flow Cytometric Assessments of Peripheral Blood Mononuclear Cells (PBMCs)
Change in Microbiome Alpha-diversity Measured by Shannon Index at the End of the Study
+1 more

Side effects data

From 2022 Phase 1 & 2 trial • 59 Patients • NCT03423121
12%
Diarrhea
8%
Abdominal cramps
8%
Nausea/Vomiting
8%
Gastroesophageal Reflux
4%
Facial rash (left)
4%
Cholecystitis
4%
Increased flatulence
100%
80%
60%
40%
20%
0%
Study treatment Arm
TUDCA Treatment
Placebo Oral Capsule

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TUDCA TreatmentExperimental Treatment1 Intervention
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Group II: Placebo oral capsulePlacebo Group1 Intervention
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tauroursodeoxycholic Acid
2018
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,253 Previous Clinical Trials
14,817,705 Total Patients Enrolled
30 Trials studying Multiple Sclerosis
2,578 Patients Enrolled for Multiple Sclerosis
Pavan Bhargava, MBBS, MDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
25 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
25 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis
2018. "A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03423121.
~9 spots leftby Apr 2025
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