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Addition to Infant Formula of 2-fucosyllactose (2-FL)

NCT03109223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2021-06-24

No results posted yet for this study

Summary

OBJECTIVES:

Primary:

The primary objective is to determine whether the mean weight gain over a 16-week interval starting on or before 14 days of life differs between infants fed one of two infant formulas as their sole source of nutrition: a commercial formula using a canola l fat blend (Control, E23) or the same formula containing the human milk oligosaccharide (Test (HMO) 2-fucosyllactose (2FL). Mean weight gain also will be compared to that of a concurrently enrolled reference group of exclusively breastfed infants.

Conditions

  • Growth of Infants

Interventions

OTHER

sole source nutrition

Infant formula

Sponsors & Collaborators

  • PBM Nutritionals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Days
Max Age
36 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-15
Primary Completion
2021-05-17
Completion
2021-05-17

Countries

  • United States
  • Honduras

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 NCT03109223 on ClinicalTrials.gov