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NCT03994315 · ClinicalTrials.gov registry record · NA
The EFFECT Study: Probiotic and HMO Supplementation in Infants
A NA study of Infant Gut Microbiome, sponsored by Evolve BioSystems.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03994315: Completed NA study of Infant Gut Microbiome, sponsored by Evolve BioSystems.
NCT03994315 is a NA study of Infant Gut Microbiome that has completed, run by Evolve BioSystems. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03994315, a NA study of Infant Gut Microbiome, has completed, sponsored by Evolve BioSystems.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Lacto-N-tetraose (LNT) is a human milk oligosaccharide (HMO) present in human colostrum and milk. HMOs are largely undigestable and have no direct nutritive benefit to the infant, but act as a prebiotic substrate for beneficial bacteria (bifidobacteria, in particular) in the infant gut. Exclusively formula-fed infants lack HMOs in their diet in the absence of naturally occurring HMOs from breast milk. The proposed clinical study will evaluate the ability of a prebiotic supplement (LNT) to initiate intestinal colonization of a probiotic strain (B. infantis EVC001) in exclusively formula-fed infants. B. infantis EVC001 has been shown to be well-tolerated and safely consumed in breastfed infants. This study also aims to evaluate the safety and tolerability of LNT in different doses when consumed daily with B. infantis EVC001.
Primary Outcome
To evaluate the ability of different doses of a prebiotic supplement (LNT) to initiate intestinal colonization of a probiotic strain (B. infantis EVC001) in exclusively formula-fed infants. DNA will be extracted from stool swab samples and will be used for quantitative PCR to determine levels of B. infantis.
Conditions Studied
Interventions
- OTHER B. infantis EVC001
- OTHER Lacto-N-tetraose (LNT)
Study Locations (1)
South Carolina
- Coastal Pediatric Research - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-09-12 |
| Est. Completion | 2020-03-13 |
| Phase | NA |
What the finished NCT03994315 record still lists
NCT03994315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Infant Gut Microbiome appearing as the primary indexed condition, and to 2 interventions - of which B. infantis EVC001 is the first listed.
NCT03994315 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT03994315 about?
NCT03994315 is a clinical study titled "The EFFECT Study: Probiotic and HMO Supplementation in Infants". Lacto-N-tetraose (LNT) is a human milk oligosaccharide (HMO) present in human colostrum and milk. HMOs are largely undigestable and have no direct nutritive benefit to the infant, but act as a prebiotic substrate for beneficial bacteria (bifidobacteria, in particular) in the infant gut. Exclusively ...
What is the current status of trial NCT03994315?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2019-09-12. Estimated completion is 2020-03-13.
What conditions does trial NCT03994315 study?
This clinical trial studies the following conditions: Infant Gut Microbiome.
What interventions are being tested in trial NCT03994315?
The interventions under investigation include: B. infantis EVC001 (OTHER), Lacto-N-tetraose (LNT) (OTHER).
Who is sponsoring clinical trial NCT03994315?
This trial is sponsored by Evolve BioSystems, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03994315 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03994315's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 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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