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NCT03611647 · ClinicalTrials.gov registry record · NA
Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT03611647: Completed NA study, sponsored by University of California, San Diego.
NCT03611647 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03611647, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
The overarching goal of this project is to compare the microbiome profiles of healthy pregnant women, both before and after the introduction of a probiotic supplement into the maternal diet. Specifically, the investigators are performing a pilot randomized double-blinded placebo-controlled trial, comparing the microbiome profiles of 40 healthy pregnant women randomized to receive an oral probiotic containing a mixture of Lactobacillus and Bifidobacterium species (20 mothers) versus an oral placebo (20 mothers) during the first/second trimester of pregnancy. For each mother, the investigators will collect biospecimens from the vagina, rectum, and urine, both before intervention, and 4-6 weeks after intervention. These biospecimens will be analyzed to obtain their microbiome profiles using next-generation sequencing. The primary outcome of interest is the vaginal microbiome, with secondary outcomes including the microbiomes of the rectum and urine. Additionally, the investigators will collect clinical data from the mother's and infant's medical records to correlate our findings with pregnancy and postnatal outcomes.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Probiotic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2018-04-01 |
| Est. Completion | 2018-12-31 |
| Phase | NA |
What the finished NCT03611647 record still lists
NCT03611647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03611647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03611647 about?
NCT03611647 is a clinical study titled "Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles". The overarching goal of this project is to compare the microbiome profiles of healthy pregnant women, both before and after the introduction of a probiotic supplement into the maternal diet. Specifically, the investigators are performing a pilot randomized double-blinded placebo-controlled trial, co...
What is the current status of trial NCT03611647?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2018-04-01. Estimated completion is 2018-12-31.
What interventions are being tested in trial NCT03611647?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Probiotic (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03611647?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03611647's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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