MedTrace Logo

Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants

NCT04593147 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2021-11-15

No results posted yet for this study

Summary

A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the composition of human milk. The purpose of this study is to demonstrate that this formulation meets nutritional requirements and supports age appropriate growth of healthy term infants.

Conditions

  • Infant Development

Interventions

OTHER

BBN

BBN to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.

OTHER

Brand

Brand to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks

Sponsors & Collaborators

  • Paidion Research, Inc.

    collaborator INDUSTRY

  • Building Block Nutritionals, LLC

    lead INDUSTRY

Principal Investigators

  • Kumar Ilangovan, MD · Medical Monitor

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2021-11-09
Completion
2021-11-09

Countries

  • United States

Study Locations

More Related Trials

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 NCT04593147 on ClinicalTrials.gov