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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 is a NA study of Infant Gut Microbiome that has completed, run by Evolve BioSystems. The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03994315
The ClinicalTrials.gov registry entry for NCT03994315 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Evolve BioSystems, which has 5 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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