AzTrials
AzTrials

Infant DevelopmentNCT03331276

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

A study testing BBN and Brand in people with Infant Development, run by Building Block Nutritionals, LLC at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 1 day to 14 daysHealthy volunteers can take part
Conditions the study is for
Infant Development
What is being tested?
BBN and Brand
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
6 sitesUnited States
Study dates
18 Sep 2017to 7 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 14 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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)
Show all 13Show fewer
  • 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.

Who cannot join

  • 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.) -

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235

  • HMG Pediatrics at Medical Plaza

    Bristol, Tennessee, 37620

  • Southeastern Pediatric Associates

    Dothan, Alabama, 36305

  • Aventiv Research

    Grove City, Ohio, 43123

  • Jackson Clinic

    Jackson, Tennessee, 38305

  • Norwich Pediatric Group

    Norwich, Connecticut, 06360

Other trials in United States

About this study

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.

Read the 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.

Being tested
BBN, Brand

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BBNOther

    Also called BBN-001

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

  • BrandOther

    Also called Enfamil

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

Study groups in NCT03331276
Study groupRoleWhat they receive
BBNExperimentalAn 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.
Receives: Other: BBN
BrandActive comparatorA Commercially available Infant Formula, for healthy term infants 0 to 12 months of age (Enfamil TM, Milk-Based Powder with Iron)
Receives: Other: Brand

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight gain

    g/d

    Measured: 16 weeks

Secondary outcomes (6)

  1. Mean stool consistency

    1= watery, 2= runny / soft, 3= musy / soft, 4= formed soft, 5= hard

    Measured: Monthly for 16 weeks

  2. Mean fussiness score

    0= less fussy than normal, 1= about the same level of fussiness as normal, 2= more fussy than normal

    Measured: Monthly 16 weeks

  3. Mean gassiness score

    0= no gas, 1= slight amount of gas, 2= moderate amout of gas, 3= excessive amount of gas

    Measured: Monthly 16 weeks

  4. Mean interleukin - 6 Concentration

    IL - 6 ng/ml

    Measured: at 16 weeks

  5. Mean interleukin - 10 Concentration

    IL - 10 pg/ml

    Measured: at 16 weeks

  6. Mean tumor necrosis factor alpha Concentration

    TNF - alpha pg/ml

    Measured: at 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start18 Sep 2017
  3. Primary completion7 Jan 2019
  4. Study completion7 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03331276
Sponsor's protocol ID
BBN-IF-001
Status last verified
Oct 2020
First submitted
21 Sep 2017
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24840511

  • 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.

    PubMed 41406156

Questions about this trial

What is this clinical trial studying?

A study testing BBN and Brand in people with Infant Development, run by Building Block Nutritionals, LLC at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight gain (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03331276, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in