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

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593147
• Other study ID #: Phase II BBN-IF-001
• Status: Completed
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: November 9, 2021

Study information

• Verified date: November 2021
• Source: Building Block Nutritionals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: November 9, 2021
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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.)

Related Conditions & MeSH terms

• Infant Development

Intervention

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

Locations

Country	Name	City	State
United States	PAS Research	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Building Block Nutritionals, LLC	Paidion Research, Inc.

Country where clinical trial is conducted

United States, 

References & 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, an — View Citation

Outcome

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