NCT03423121

A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis

A Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Progressive Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-19
• Primary completion: 2022-04-28
• Completion: 2022-07-05
• First posted: 2018-02-06
• Last updated: 2023-05-03
• Results posted: 2023-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study