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A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis

NCT03423121 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-05-03

Study results available
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Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pavan Bhargava, MBBS, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2022-04-28
Completion
2022-07-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03423121 on ClinicalTrials.gov