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NCT04721912 · ClinicalTrials.gov registry record · Phase 3
Group B Streptococcus Response After Probiotic Exposure
A Phase 3 study, sponsored by University of New Mexico.
- Completed
- Registry status
- Phase 3
- Development phase
- 68
- Enrollment target
NCT04721912: Completed Phase 3 study, sponsored by University of New Mexico.
NCT04721912 is a Phase 3 study that has completed, run by University of New Mexico. The registered enrollment target is 68 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04721912, a Phase 3 study, has completed, sponsored by University of New Mexico.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 68 participants
- Enrollment target
Study Summary
This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at term. Investigators hope to address the question of whether prenatal oral probiotic use, taken by healthy low risk GBS positive women from approximately 37 weeks gestation until the time of birth, will reduce the number of women who test positive for GBS at the time of admission to Labor and Delivery (L\&D).
Primary Outcome
Qualitative GBS colonization (positive versus negative)
Interventions
- DRUG Probiotic dietary supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2020-12-24 |
| Est. Completion | 2023-08-31 |
| Phase | Phase 3 |
What the finished NCT04721912 record still lists
NCT04721912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Probiotic dietary supplement is the first listed.
NCT04721912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04721912 about?
NCT04721912 is a clinical study titled "Group B Streptococcus Response After Probiotic Exposure". This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at term. Investigators hope to address the question of whether prenatal o...
What is the current status of trial NCT04721912?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 68 participants. The study started on 2020-12-24. Estimated completion is 2023-08-31.
What interventions are being tested in trial NCT04721912?
The interventions under investigation include: Probiotic dietary supplement (DRUG).
Who is sponsoring clinical trial NCT04721912?
This trial is sponsored by University of New Mexico, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04721912's enrollment target sits among peer trials
68 1796th of 2000 higher than 205 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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