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NCT03939546 · ClinicalTrials.gov registry record · NA
The FOUNDATION Study
A NA study, sponsored by Evolve BioSystems.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT03939546: Completed NA study, sponsored by Evolve BioSystems.
NCT03939546 is a NA study that has completed, run by Evolve BioSystems. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03939546, a NA study, has completed, sponsored by Evolve BioSystems.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint. This particular strain of Bifidobacterium has been shown to uniquely utilize oligosaccharides found in human breast milk, possibly providing a nutritional benefit for the infant consuming breast milk when B. infantis is colonized in the gut.
Primary Outcome
Tolerability of B. infantis EVC001 in preterm infants as determined by Adverse Events. Frequency of treatment-emergent adverse events (TEAEs), serious TEAEs and TEAEs causing premature discontinuation will be provided by treatment group.
Interventions
- OTHER B. infantis EVC001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-07-03 |
| Est. Completion | 2021-06-01 |
| Phase | NA |
What the finished NCT03939546 record still lists
NCT03939546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which B. infantis EVC001 is the first listed.
NCT03939546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03939546 about?
NCT03939546 is a clinical study titled "The FOUNDATION Study". The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint. This particular strain of Bifidobacterium has been shown to uniquely utilize oligosaccharides found in human breast milk, possibly providing a nutritional benefit ...
What is the current status of trial NCT03939546?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2019-07-03. Estimated completion is 2021-06-01.
What interventions are being tested in trial NCT03939546?
The interventions under investigation include: B. infantis EVC001 (OTHER).
Who is sponsoring clinical trial NCT03939546?
This trial is sponsored by Evolve BioSystems, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03939546's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 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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