Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. 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.
Primary Outcome
Safety and tolerability will be assessed based on treatment-related adverse events in the two arms.
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 |
What the finished NCT03423121 record still lists
NCT03423121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03423121 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03423121's enrollment target sits among peer trials
59 895th of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03801083 · 59 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
- NCT04332367 · 59 participants · Phase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
- NCT05489575 · 59 participants · NA
CPAP for the Treatment of Supine Hypertension
- NCT06721689 · 59 participants · Phase 1
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI