Clinical trial NCT04593147: Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants
Official title: Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Lead sponsor: Building Block Nutritionals, LLC
Sponsor class: INDUSTRY
Collaborators: name: Paidion Research, Inc.
First posted: 2020-10-19
Enrollment: 131
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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.

Eligibility 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.)

Primary outcomes:
measure: Weight gain
timeFrame: 16 weeks
Secondary outcomes:
measure: Mean stool consistency
timeFrame: 16 weeks
measure: Mean fussiness score
timeFrame: 16 weeks
measure: Mean gassiness score
timeFrame: 16 weeks
measure: Mean interleukin - 6 Concentration
timeFrame: 16 weeks
measure: Mean interleukin - 10 Concentration
timeFrame: 16 weeks
measure: Mean tumor necrosis factor alpha concentration
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: PAS Research
state: Florida
Study officials:
affiliation: Medical Monitor
name: Kumar Ilangovan, MD
role: STUDY_DIRECTOR
References:
citation: 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.