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NCT03423121 · ClinicalTrials.gov registry record · Phase 1
A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT03423121: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT03423121 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 59 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03423121, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo oral capsule
- DRUG Tauroursodeoxycholic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2018-06-19 |
| Est. Completion | 2022-07-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03423121
The ClinicalTrials.gov registry entry for NCT03423121 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03423121 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03423121 about?
NCT03423121 is a clinical study titled "A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis". 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 ...
What is the current status of trial NCT03423121?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2018-06-19. Estimated completion is 2022-07-05.
What interventions are being tested in trial NCT03423121?
The interventions under investigation include: Placebo oral capsule (DRUG), Tauroursodeoxycholic Acid (DRUG).
Who is sponsoring clinical trial NCT03423121?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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