Healthy GrowthNCT05783037
Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula
A study testing New Organic Infant Formula and Commercial Organic Infant Formula in people with Healthy Growth, run by Bobbie Baby, Inc at 1 site in United States.
Trial summary
The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Read more about this study
- Who is it for?
- Ages 0 to 11 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Growth
- What is being tested?
- New Organic Infant Formula and Commercial Organic Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 7 Dec 2025
- 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 0 to 11 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days)
- Birth weight of ≥ 2,500 g and ≤ 4,500 g
- Postnatal age ≤ 11 days at time of enrollment
- Singleton
- Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding)
- Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, reporting of AEs, and urine collection)
- Caregiver willing and able to sign IRB approved informed consent
Who cannot join
- Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
- Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
- Maternal, fetal, or infant medical history thought to have an impact on growth and/or development (substance abuse, positive HIV status, opioid exposure, or diabetes requiring insulin)
- Infant receiving prescription medication
- Infant with a known history of cow's milk protein allergy, excluding lactose intolerance
- Infant who has been treated with antibiotics or medications that may impact growth, GI tolerance and/or development
- Infant or family history (grandparent, parent, sibling) with known folate metabolism disorder
- Caregiver intent to feed non-study formula or solid food during the study
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Therefore, this study also includes a group of breastfed babies for additional comparison.
Read the detailed description
This is a 16 week, double-blind, randomized, controlled trial designed to demonstrate that a new infant formula for term infants supports age-appropriate growth. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96
- Conditions
- Healthy Growth
- Being tested
- New Organic Infant Formula, Commercial Organic Infant Formula
- Keywords
- Organic, Bobbie, Bobbie Baby, Weight, Growth, Breastfeeding, Infant Formula, Growth and Tolerance
- Medical subject headings
- Body Weight, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Organic Infant FormulaOther
New organic infant formula fed daily ad libitum
Commercial Organic Infant FormulaOther
Commercially available organic infant formula fed daily ad libitum
| Study group | Role | What they receive |
|---|---|---|
| New Organic Infant Formula | Experimental | New organic infant formula for healthy term infants Receives: Other: New Organic Infant Formula |
| Commercial Organic Infant Formula | Active comparator | Commercially available organic infant formula for healthy term infants Receives: Other: Commercial Organic Infant Formula |
| Breastfed Reference Group | No intervention | Breastmilk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain Velocity
Weight Gain Velocity (g/day)
Measured: Study Day 1 to Study Day 112
Secondary outcomes (5)
Length
Length and Length Gain Velocity (cm)
Measured: Study Day 1 to Study Day 112
Head Circumference
Head Circumference and Head Circumference Gain Velocity (cm)
Measured: Study Day 1 to Study Day 112
Formula Intake
Formula Intake Volume (oz/kg/day)
Measured: Study Day 1 to Study Day 112
Formula Intake (2)
Formula Intake Volume (oz/day)
Measured: Study Day 1 to Study Day 112
Anthropometry Z-scores
Weight for age Z-score, Length for age Z-score, Weight for length Z-score, Head circumference for age Z-score
Measured: Study Day 1 to Study Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start29 Mar 2023
- Primary completion4 Dec 2025
- Study completion7 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy GrowthStudies 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
- A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bobbie Baby, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Lynch, MD, Principal investigator, SPRIM Pro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783037
- Sponsor's protocol ID
- BB-01
- Status last verified
- Feb 2026
- First submitted
- 16 Mar 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula
- ClinicalTrials.gov ID
- NCT05783037
- Acronym / sponsor ID
- BB-01
- Conditions
- Healthy Growth
- Keywords
- Organic, Bobbie, Bobbie Baby, Weight, Growth, Breastfeeding, Infant Formula, Growth and Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Bobbie Baby, IncIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 7 Dec 2025 (actual)
- First posted
- 24 Mar 2023 (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.
The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Therefore, this study also includes a group of breastfed babies for additional comparison.
Detailed description
This is a 16 week, double-blind, randomized, controlled trial designed to demonstrate that a new infant formula for term infants supports age-appropriate growth. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
| Arm | Type | Receives |
|---|---|---|
| New Organic Infant Formula | Experimental | Other: New Organic Infant FormulaNew organic infant formula for healthy term infants |
| Commercial Organic Infant Formula | Active comparator | Other: Commercial Organic Infant FormulaCommercially available organic infant formula for healthy term infants |
| Breastfed Reference Group | No intervention | –Breastmilk |
Who may qualify
- Ages
- 0 to 11 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days)
- Birth weight of ≥ 2,500 g and ≤ 4,500 g
- Postnatal age ≤ 11 days at time of enrollment
- Singleton
- Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding)
Key exclusion criteria (8 listed)
- Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
- Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
- Maternal, fetal, or infant medical history thought to have an impact on growth and/or development (substance abuse, positive HIV status, opioid exposure, or diabetes requiring insulin)
- Infant receiving prescription medication
- Infant with a known history of cow's milk protein allergy, excluding lactose intolerance
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 |
|---|---|---|
| New Organic Infant FormulaNew organic infant formula fed daily ad libitum | Other | New Organic Infant Formula |
| Commercial Organic Infant FormulaCommercially available organic infant formula fed daily ad libitum | Other | Commercial Organic Infant Formula |
Primary outcome
Weight Gain Velocity
Time frame: Study Day 1 to Study Day 112
Weight Gain Velocity (g/day)
5 secondary outcomes
Length
Time frame: Study Day 1 to Study Day 112
Head Circumference
Time frame: Study Day 1 to Study Day 112
Formula Intake
Time frame: Study Day 1 to Study Day 112
Formula Intake (2)
Time frame: Study Day 1 to Study Day 112
Anthropometry Z-scores
Time frame: Study Day 1 to Study Day 112
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 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Growth
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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.
Thomas Lynch, MD principal investigator
SPRIM Pro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Organic Infant Formula and Commercial Organic Infant Formula in people with Healthy Growth, run by Bobbie Baby, Inc 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 7 inclusion and 8 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 5 Feb 2026. 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 Velocity (time frame: Study Day 1 to Study Day 112). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2026.