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NCT03476447 · ClinicalTrials.gov registry record · NA
Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants
A NA study, sponsored by Evolve BioSystems.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT03476447: Completed NA study, sponsored by Evolve BioSystems.
NCT03476447 is a NA study that has completed, run by Evolve BioSystems. The registered enrollment target is 40 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
NCT03476447, a NA study, has completed, sponsored by Evolve BioSystems.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
The REMEDI Study is a single-center, prospective, double-blind, randomized, placebo-controlled trial of multiple doses of B. infantis EVC001 supplementation in healthy term breastfed infants.
Primary Outcome
The difference in levels of infant fecal B. infantis (as measured by B. infantis qPCR) between B. infantis EVC001 supplementation and placebo supplementation on Day 28.
Interventions
- OTHER B. infantis EVC001
- OTHER Lactose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-04-06 |
| Est. Completion | 2019-04-03 |
| Phase | NA |
What the finished NCT03476447 record still lists
NCT03476447 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 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 B. infantis EVC001 is the first listed.
NCT03476447 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03476447 about?
NCT03476447 is a clinical study titled "Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants". The REMEDI Study is a single-center, prospective, double-blind, randomized, placebo-controlled trial of multiple doses of B. infantis EVC001 supplementation in healthy term breastfed infants.
What is the current status of trial NCT03476447?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2018-04-06. Estimated completion is 2019-04-03.
What interventions are being tested in trial NCT03476447?
The interventions under investigation include: B. infantis EVC001 (OTHER), Lactose (OTHER).
Who is sponsoring clinical trial NCT03476447?
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 NCT03476447's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 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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