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

NCT03331276 | Completed DMC

• 1 other identifier: BBN-IF-001
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Weight gain

  g/d

  16 weeks

Secondary Outcomes (6)

• Mean stool consistency

  Monthly for 16 weeks

• Mean fussiness score

  Monthly 16 weeks

• Mean gassiness score

  Monthly 16 weeks

• Mean interleukin - 6 Concentration

  at 16 weeks

• Mean interleukin - 10 Concentration

  at 16 weeks

Study Arms (2)

BBN

EXPERIMENTAL

An experimental Infant Formula, Milk-Based Powder with Iron, for healthy term infants 0 to 12 months of age with high Sn-2 Palmitate, Alpha Lactalbumin and Osteopontin to better mimic human milk.

Other: BBN

Brand

ACTIVE COMPARATOR

A Commercially available Infant Formula, for healthy term infants 0 to 12 months of age (Enfamil TM, Milk-Based Powder with Iron)

Other: Brand

Interventions

BBN OTHER

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

Also known as: BBN-001

BBN

Brand OTHER

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

Also known as: Enfamil

Brand

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants will be eligible to participate if they meet all of the following conditions. At birth the infant must be:
• 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
• At the time of the baseline/enrollment visit, infants must be:
• 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 soure 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.

You may not qualify if:

• 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.) -

Sponsors & Collaborators

• Building Block Nutritionals, LLC: lead
• Paidion Research, Inc.: collaborator

Study Sites (6)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

Southeastern Pediatric Associates

Dothan, Alabama, 36305, United States

Location

Norwich Pediatric Group

Norwich, Connecticut, 06360, United States

Location

Aventiv Research

Grove City, Ohio, 43123, United States

Location

HMG Pediatrics at Medical Plaza

Bristol, Tennessee, 37620, United States

Location

Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

Related Publications (2)

• 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.

  PMID: 24840511 RESULT

• Fleming SA, Flunkert S, Kvistgaard AS, McGrath J, Glover DK. New infant formulas for healthy term infants: A randomized, controlled, double-blind, multicenter, non-inferiority design safety study. PLoS One. 2025 Dec 17;20(12):e0336689. doi: 10.1371/journal.pone.0336689. eCollection 2025.

  PMID: 41406156 DERIVED

MeSH Terms

Interventions

lepirudin

Study Officials

• Laurie Dunn, MD

  Paidion Research, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Formula feed infants will be randomized to receive either a new 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.

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: November 6, 2017
• Study Start: September 18, 2017
• Primary Completion: January 7, 2019
• Study Completion: January 7, 2019
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)