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NCT03646487 · ClinicalTrials.gov registry record · NA
A Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Women
A NA study of Stress, Psychological and Pregnancy, High Risk, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03646487: Completed NA study of Stress, Psychological and Pregnancy, High Risk, sponsored by University of Illinois at Chicago.
NCT03646487 is a NA study of Stress, Psychological and Pregnancy, High Risk that has completed, run by University of Illinois at Chicago. The registered enrollment target is 20 participants, below the 171-participant average among 43 other Stress, Psychological trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03646487, a NA study of Stress, Psychological and Pregnancy, High Risk, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this randomized supplementation feasibility trial is to learn about the feasibility and preliminary efficacy of the probiotic, lactobacillus plantarum 299v (Lp299v), in pregnant individuals at-risk for iron deficiency anemia. The main questions it aims to answer are: * Is daily oral Lp299v a feasible and tolerable intervention for pregnant individuals to uptake? * Does daily oral Lp299v in pregnancy impact maternal and neonatal cord hematological and iron status parameters? Participants will be randomly assigned to one of two treatment groups: daily intake or probiotic Lp299v + prenatal vitamin with iron or placebo + prenatal vitamin with iron from 15-20 weeks of gestation through delivery. Researchers will compare the two treatment groups to see if there is a difference in the feasibility of the intervention and the preliminary efficacy on maternal and neonatal cord hematological and iron status parameters.
Primary Outcome
Mean adherence to the supplement regimen using Pillsy smart bottles and standard pill counts.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Probiotic LP299v 10x10 colony forming units in capsule form
- OTHER Placebo in capsule form
Study Locations (1)
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-11-19 |
| Est. Completion | 2020-07-21 |
| Phase | NA |
What the finished NCT03646487 record still lists
NCT03646487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 171-participant average among 43 other Stress, Psychological trials with a reported enrollment target (88% lower).
The record links to 3 conditions, with Stress, Psychological appearing as the primary indexed condition, and to 2 interventions - of which Probiotic LP299v 10x10 colony forming units in capsule form is the first listed.
NCT03646487 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03646487 about?
NCT03646487 is a clinical study titled "A Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Women". The goal of this randomized supplementation feasibility trial is to learn about the feasibility and preliminary efficacy of the probiotic, lactobacillus plantarum 299v (Lp299v), in pregnant individuals at-risk for iron deficiency anemia. The main questions it aims to answer are: * Is daily oral Lp...
What is the current status of trial NCT03646487?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2018-11-19. Estimated completion is 2020-07-21.
What conditions does trial NCT03646487 study?
This clinical trial studies the following conditions: Stress, Psychological, Pregnancy, High Risk, Iron-deficiency.
What interventions are being tested in trial NCT03646487?
The interventions under investigation include: Probiotic LP299v 10x10 colony forming units in capsule form (DIETARY_SUPPLEMENT), Placebo in capsule form (OTHER).
Who is sponsoring clinical trial NCT03646487?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03646487 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stress, Psychological
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03646487's enrollment target sits among peer trials
20 42nd of 43 higher than 2 of 43 other Stress, Psychological trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress, Psychological 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.
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