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NCT04192487 · ClinicalTrials.gov registry record · Phase 4
Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea
A Phase 4 study, sponsored by Napo Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT04192487: Completed Phase 4 study, sponsored by Napo Pharmaceuticals.
NCT04192487 is a Phase 4 study that has completed, run by Napo Pharmaceuticals. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04192487, a Phase 4 study, has completed, sponsored by Napo Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study Summary
This study is intended to evaluate: 1. Any changes in the gut microbiome from baseline compared to end of study in both healthy (HIV-negative) subjects and HIV+ patients with or without chronic diarrhea, following one month of treatment with crofelemer (Mytesi), delayed release 125 mg tablets twice daily (BID) following one month of treatment. 2. The safety and tolerability of crofelemer, (Mytesi) delayed release 125 mg tablets BID in healthy (HIV-negative) volunteers and HIV+ patients following one month of treatment.
Primary Outcome
Stool microbiomes will be evaluated to compare the differences in the stool microbiome at Visits 2, (Day 1) Visit 3 (Day 30) and Visit 4 (Day 60) using a proprietary microbiome statistical tool (μScope) and R statistical computing and graphics software.
Interventions
- DRUG Crofelemer delayed-release tablets 125mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-10-22 |
| Est. Completion | 2021-08-31 |
| Phase | Phase 4 |
What the finished NCT04192487 record still lists
NCT04192487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Crofelemer delayed-release tablets 125mg is the first listed.
NCT04192487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04192487 about?
NCT04192487 is a clinical study titled "Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea". This study is intended to evaluate: 1. Any changes in the gut microbiome from baseline compared to end of study in both healthy (HIV-negative) subjects and HIV+ patients with or without chronic diarrhea, following one month of treatment with crofelemer (Mytesi), delayed release 125 mg tablets twice...
What is the current status of trial NCT04192487?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2019-10-22. Estimated completion is 2021-08-31.
What interventions are being tested in trial NCT04192487?
The interventions under investigation include: Crofelemer delayed-release tablets 125mg (DRUG).
Who is sponsoring clinical trial NCT04192487?
This trial is sponsored by Napo Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04192487's enrollment target sits among peer trials
17 1854th of 2000 higher than 132 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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