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

• ClinicalTrials.gov Identifier: NCT04593147
• Recruitment Status: Completed
• First Posted: October 19, 2020
• Last Update Posted: November 15, 2021
• Sponsor: Building Block Nutritionals, LLC
• Collaborator: Paidion Research, Inc.
• Information provided by (Responsible Party): Building Block Nutritionals, LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infant Development	Other: BBN; Other: Brand	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 131 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants.
• Primary Purpose: Other
• Official Title: Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants
• Actual Study Start Date: October 14, 2020
• Actual Primary Completion Date: November 9, 2021
• Actual Study Completion Date: November 9, 2021

Arms and Interventions

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 Name: 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 Name: Enfamil

Outcome Measures

Primary Outcome Measures :

1. Weight gain [ Time Frame: 16 weeks ]
   Change grams per day

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: up to 14 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.)

Contacts and Locations

Locations

United States, Florida

PAS Research

Tampa, Florida, United States, 33613

Sponsors and Collaborators

Building Block Nutritionals, LLC

Paidion Research, Inc.

Investigators

• Study Director: Kumar Ilangovan, MD; Medical Monitor

More Information

Publications of Results:

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.

• Responsible Party: Building Block Nutritionals, LLC
• ClinicalTrials.gov Identifier: NCT04593147
• Other Study ID Numbers: Phase II BBN-IF-001
• First Posted: October 19, 2020
• Last Update Posted: November 15, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No