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A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis

Johns Hopkins University logo

Johns Hopkins University

Status and phase

Completed
Phase 2
Phase 1

Conditions

Progressive Multiple Sclerosis

Treatments

Drug: Placebo oral capsule
Drug: Tauroursodeoxycholic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT03423121
IRB00144766

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion 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

Exclusion criteria

  • 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
  • Known history of other neuroinflammatory, neurodegenerative or systemic autoimmune disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

59 participants in 2 patient groups, including a placebo group

TUDCA Treatment
Experimental group
Description:
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Treatment:
Drug: Tauroursodeoxycholic Acid
Placebo oral capsule
Placebo Comparator group
Description:
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Treatment:
Drug: Placebo oral capsule

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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