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NCT03671785 · ClinicalTrials.gov registry record · Phase 1
Study of the Fecal Microbiome in Patients With Parkinson's Disease
A Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03671785: Completed Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
NCT03671785 is a Phase 1 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03671785, a Phase 1 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is to characterize the intestinal microbiome in subjects with Parkinson's disease and to determine safety and trends in improvements in diversity of colonic microbiome following administration of lyophilized PRIM-DJ2727
Primary Outcome
The Shannon diversity index is used to characterize species diversity in a community. Shannon's index accounts for both abundance and evenness of the species present. A high index value would represent a diverse and equally distributed community, and lower values represent a less diverse community. A value of 0 would represent a community with just one species. Typical values are generally between 1.5 and 3.5.
Interventions
- DRUG PRIM-DJ2727
- DRUG Placebo oral capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-05-15 |
| Est. Completion | 2022-10-12 |
| Phase | Phase 1 |
What the finished NCT03671785 record still lists
NCT03671785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which PRIM-DJ2727 is the first listed.
NCT03671785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03671785 about?
NCT03671785 is a clinical study titled "Study of the Fecal Microbiome in Patients With Parkinson's Disease". The purpose of this study is to characterize the intestinal microbiome in subjects with Parkinson's disease and to determine safety and trends in improvements in diversity of colonic microbiome following administration of lyophilized PRIM-DJ2727
What is the current status of trial NCT03671785?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2019-05-15. Estimated completion is 2022-10-12.
What interventions are being tested in trial NCT03671785?
The interventions under investigation include: PRIM-DJ2727 (DRUG), Placebo oral capsule (DRUG).
Who is sponsoring clinical trial NCT03671785?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03671785's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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
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