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NCT05541003 · ClinicalTrials.gov registry record · Phase 2
Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome
A Phase 2 study, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT05541003: Completed Phase 2 study, sponsored by Rutgers, The State University of New Jersey.
NCT05541003 is a Phase 2 study that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05541003, a Phase 2 study, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study aims to use a high-fiber supplementation, an intervention known to create shifts in the gut microbiota towards a healthier structure, to explore the relationship between gut microbiota, appetite control and feeding behavior in PWS patients.
Primary Outcome
Alpha Diversity measured by Shannon index. The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community.
Interventions
- DRUG NBT-NM108
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-01-06 |
| Est. Completion | 2023-05-30 |
| Phase | Phase 2 |
What the finished NCT05541003 record still lists
NCT05541003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which NBT-NM108 is the first listed.
NCT05541003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05541003 about?
NCT05541003 is a clinical study titled "Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome". This study aims to use a high-fiber supplementation, an intervention known to create shifts in the gut microbiota towards a healthier structure, to explore the relationship between gut microbiota, appetite control and feeding behavior in PWS patients.
What is the current status of trial NCT05541003?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2023-01-06. Estimated completion is 2023-05-30.
What interventions are being tested in trial NCT05541003?
The interventions under investigation include: NBT-NM108 (DRUG).
Who is sponsoring clinical trial NCT05541003?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05541003's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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