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

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.

Study Overview

• Status: Completed
• Conditions: Infant Development
• Intervention / Treatment: Other: BBN; Other: Brand

Detailed Description

This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants. FF infants will be randomized to receive either a experimental infant formula, formulated for healthy term infants (BBN) or a commercially available infant formula for healthy term infants (Brand). Infants will consume the formula for a total of 16-weeks; infant growth, serum markers for inflammation and tolerance to the formulas will be assessed throughout the study.

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33613
      • Pas Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Infants will be eligible to participate if they meet all of the following conditions. At birth, the infant must be:

Inclusion Criteria:

• Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant
• Have a birth weight of ≥ 2500 grams
• Designated as healthy by a physician
• ≤14 days post-natal age (Date of Birth = Day 0)
• Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• Head circumference for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment
• Only infants whose parent(s) or legal guardian(s) have decided to feed infant formula as the sole source of nutrition, will be approached for potential study enrollment
• Have parent(s) or legal guardian(s) who agree to feed the study formula to the study subject as his/her sole source of nutrition for the duration of the study
• Have parent(s) or legal guardian(s) who have read and voluntarily signed an Informed Consent form approved by the Institutional Review Board prior to any participation in the study.

Infants will be ineligible if they have any of the following conditions that are judged by a physician to interfere with the infant's normal growth, development, and/or tolerance to an infant formula:

Exclusion Criteria:

• Infants will be ineligible if they have any of the following conditions that are judged by a physician to interfere with the infant's normal growth, development, and/or tolerance to an infant formula
• Show evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician);
• Show evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases;
• Have a maternal history with known adverse effects on the fetus and/or the newborn infant, such as diabetes (gestational diabetes is acceptable if infant's birth weight is < 4300 g), active tuberculosis, perinatal infection, or substance abuse
• Have a family history of cow's milk protein intolerance/allergy
• Are an infant from a multiple birth (twin, triplet, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BBN; An experimental Infant Formula, Milk-Based Powder with Iron, for healthy term infants 0 to 12 months of age with Sn-2 Palmitate, Alpha Lactalbumin and Lactoferrin to better mimic human milk.	Other: BBN; BBN to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.; Other Names: BBN-102
ACTIVE_COMPARATOR: Brand; A commercially available Infant Formula, for healthy term infants 0 to 2 months of age (Enfamil TM, Milk-Based Powder with Iron).	Other: Brand; Brand to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks; Other Names: Enfamil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight gain	Change grams per day	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean stool consistency	1= watery, 2= runny / soft, 3= mushy / soft, 4= formed soft, 5= hard	16 weeks
Mean fussiness score	0= less fussy than normal, 1= about the same level of fussiness as normal, 2= more fussy than normal	16 weeks
Mean gassiness score	0= no gas, 1= slight amount of gas, 2= moderate amount of gas, 3= excessive amount of gas	16 weeks
Mean interleukin - 6 Concentration	IL - 6 ng/ml	16 weeks
Mean interleukin - 10 Concentration	IL - 10 pg/ml	16 weeks
Mean tumor necrosis factor alpha concentration	TNF - alpha pg/ml	16 weeks

Collaborators and Investigators

• Sponsor: Building Block Nutritionals, LLC
• Collaborators: Paidion Research, Inc.
• Investigators: Study Director: Kumar Ilangovan, MD, Medical Monitor

Publications and helpful links

General Publications

• Yao M, Lien EL, Capeding MR, Fitzgerald M, Ramanujam K, Yuhas R, Northington R, Lebumfacil J, Wang L, DeRusso PA. Effects of term infant formulas containing high sn-2 palmitate with and without oligofructose on stool composition, stool characteristics, and bifidogenicity. J Pediatr Gastroenterol Nutr. 2014 Oct;59(4):440-8. doi: 10.1097/MPG.0000000000000443.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2020
• Primary Completion (ACTUAL): November 9, 2021
• Study Completion (ACTUAL): November 9, 2021

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Phase II BBN-IF-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No