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

NCT04593147 | Completed DMC

• 1 other identifier: Phase II BBN-IF-001
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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

  Change grams per day

  16 weeks

Secondary Outcomes (6)

• Mean stool consistency

  16 weeks

• Mean fussiness score

  16 weeks

• Mean gassiness score

  16 weeks

• Mean interleukin - 6 Concentration

  16 weeks

• Mean interleukin - 10 Concentration

  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 Sn-2 Palmitate, Alpha Lactalbumin and Lactoferrin to better mimic human milk.

Other: BBN

Brand

ACTIVE COMPARATOR

A commercially available Infant Formula, for healthy term infants 0 to 2 months of age (Enfamil TM, Milk-Based Powder with Iron).

Other: Brand

Interventions

BBN OTHER

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

Also known as: BBN-102

BBN

Brand OTHER

Brand to be fed 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:

• 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:

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 (1)

PAS Research

Tampa, Florida, 33613, United States

Location

Related Publications (1)

• 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

MeSH Terms

Interventions

lepirudin

Study Officials

• Kumar Ilangovan, MD

  Medical Monitor

  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: October 13, 2020
• First Posted: October 19, 2020
• Study Start: October 14, 2020
• Primary Completion: November 9, 2021
• Study Completion: November 9, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)