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The EFFECT Study: Probiotic and HMO Supplementation in Infants

NCT03994315 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-07-09

No results posted yet for this 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

  • Infant Gut Microbiome

Interventions

OTHER

B. infantis EVC001

Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)

OTHER

Lacto-N-tetraose (LNT)

LNT is a human milk oligosaccharide (HMO) found in human breast milk and is a selective prebiotic for B. infantis.

Sponsors & Collaborators

  • Evolve BioSystems, Inc.

    lead INDUSTRY

Principal Investigators

  • Rimon Youssef, MD · Coastal Pediatric Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
60 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-12
Primary Completion
2020-03-13
Completion
2020-03-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03994315 on ClinicalTrials.gov