Infant DevelopmentNCT04593147
Phase II 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 1 site in United States.
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
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2020to 9 Nov 2021
- 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
- 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
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- 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:
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
1 site in 1 country.
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.
- Conditions
- Infant Development
- 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-102
BBN to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.
BrandOther
Also called Enfamil
Brand to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Brand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Change grams per day
Measured: 16 weeks
Secondary outcomes (6)
Mean stool consistency
1= watery, 2= runny / soft, 3= mushy / soft, 4= formed soft, 5= hard
Measured: 16 weeks
Mean fussiness score
0= less fussy than normal, 1= about the same level of fussiness as normal, 2= more fussy than normal
Measured: 16 weeks
Mean gassiness score
0= no gas, 1= slight amount of gas, 2= moderate amount of gas, 3= excessive amount of gas
Measured: 16 weeks
Mean interleukin - 6 Concentration
IL - 6 ng/ml
Measured: 16 weeks
Mean interleukin - 10 Concentration
IL - 10 pg/ml
Measured: 16 weeks
Mean tumor necrosis factor alpha concentration
TNF - alpha pg/ml
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start14 Oct 2020
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Building Block Nutritionals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Paidion Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Kumar Ilangovan, MD, Study director, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593147
- Sponsor's protocol ID
- Phase II BBN-IF-001
- Status last verified
- Nov 2021
- First submitted
- 13 Oct 2020
- Last updated
- 15 Nov 2021
- 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants
- ClinicalTrials.gov ID
- NCT04593147
- Acronym / sponsor ID
- Phase II BBN-IF-001
- Conditions
- Infant Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Building Block Nutritionals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Paidion Research, Inc.
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BBN | Experimental | Other: BBNAn 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. |
| Brand | Active comparator | Other: BrandA commercially available Infant Formula, for healthy term infants 0 to 2 months of age (Enfamil TM, Milk-Based Powder with Iron). |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBNAlso: BBN-102BBN to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks. | Other | BBN |
| BrandAlso: EnfamilBrand to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks | Other | Brand |
Primary outcome
Weight gain
Time frame: 16 weeks
Change grams per day
6 secondary outcomes
Mean stool consistency
Time frame: 16 weeks
Mean fussiness score
Time frame: 16 weeks
Mean gassiness score
Time frame: 16 weeks
Mean interleukin - 6 Concentration
Time frame: 16 weeks
Mean interleukin - 10 Concentration
Time frame: 16 weeks
Mean tumor necrosis factor alpha concentration
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Results publication: PubMed 24840511Yao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kumar Ilangovan, MD study director
Medical Monitor
1 site in 1 country: see every site and its status.
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 1 site 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 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 NCT04593147, which also lists 1 linked publication.
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 15 Nov 2021.