Infant DevelopmentNCT05947084
Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas
A study testing Infant Formula in people with Infant Development, run by Aussie Bubs, Inc. at 29 sites in United States.
Trial summary
A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks. 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?
- Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 29 sitesUnited States
- Study dates
- 31 Aug 2023to 30 Jun 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 1 day to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy Term Infant
Who cannot join
- Any health condition that would negatively impact infant feeding and growth.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Kentucky Pediatric Research
Bardstown, Kentucky, 40004
Helios Clinical Research-Burleson
Burleson, Texas, 76028
Advance Pediatric Associates
Centennial, Colorado, 80015
Coastal Ped Research-Charleston
Charleston, South Carolina, 29414
Velocity Clinical Research-Durham
Durham, North Carolina, 27701
Cyn3rgy
Gresham, Oregon, 97030
PAS Research Henderson
Henderson, Nevada, 89014
Helios Clinical Research-Houston
Houston, Texas, 77008
Leavitt Clinical Research
Idaho Falls, Idaho, 83404
Symphony Clinical Research
Jacksonville, Florida, 32216
PAS Research Vegas
Las Vegas, Nevada, 89128
Frontier Pediatric Research, LLC
Lincoln, Nebraska, 68516
Magnolia Clinical Research, LLC
Lutcher, Louisiana, 70071
Velocity Clinical Research-Macon
Macon, Georgia, 31210
Prime Clinical Research, Inc
Mansfield, Texas, 76063
PAS Research McAllen
McAllen, Texas, 78504
AVIATI Healthcare & Clinical Research
Memphis, Tennessee, 38115
Clintheory Healthcare Miami
North Miami Beach, Florida, 33162
Hightower Clinical-Oklahoma City
Oklahoma City, Oklahoma, 73114
Springs Medical Research
Owensboro, Kentucky, 42303
Velocity Clinical Research-Phoenix
Phoenix, Arizona, 85006
PAS Pittsburgh
Pittsburgh, Pennsylvania, 15227
Hightower Clinical-Shawnee
Shawnee, Oklahoma, 74804
Velocity Clinical Research-Slidell, LA
Slidell, Louisiana, 70458
Coastal Ped Research-Summerville
Summerville, South Carolina, 29486
PAS Research Tampa
Tampa, Florida, 33607
UpTo Trials
Tampa, Florida, 33612
Helios Clinical Research-Weatherford
Weatherford, Texas, 76086
Backtee Holdings, LLC
Wellington, Florida, 33414
About this study
Official title: Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas. A 4 Month, Prospective, Randomized, Multi Center Clinical Trial.
A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.
Read the detailed description
A Growth Monitoring Study conducted according to FDA established guidelines to evaluate the test infant formulas ability to promote normal growth and development.
- Conditions
- Infant Development
- Being tested
- Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant FormulaOther
Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period
| Study group | Role | What they receive |
|---|---|---|
| Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula | Experimental | Infant formula meets all nutrient requirements of the FDA. Receives: Other: Infant Formula |
| Study Formula 2_Goat Milk Infant Formula | Experimental | Infant Formula meets all nutrient requirements of the FDA. Receives: Other: Infant Formula |
| Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein | Experimental | Infant Formula meets all nutrient requirements of the FDA. Receives: Other: Infant Formula |
| Study Formula 4_USDA Organic iron fortified infant formula | Active comparator | Infant Formula meets all nutrient requirements of the FDA. Receives: Other: Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain (g) from study entry to 16 weeks of study.
Growth Monitoring Study
Measured: 16 weeks of Clinical Study
Secondary outcomes (3)
Recumbent length gain (cm) from study entry to 16 weeks of study.
Growth Monitoring Study
Measured: 16 weeks of Clinical Study
Head Circumference gain (cm) from study entry to 16 weeks of study
Growth Monitoring Study
Measured: 16 weeks of Clinical Study
Tolerance of study formulas over 16 weeks of study
Tolerance of the infant to the study formulas will be evaluated 5 times through the use of study diaries for 3 days before each study visit.
Measured: 16 weeks of Clinical Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start31 Aug 2023
- Primary completion19 Apr 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomization and exclusive feeding of study formulas by 14 days of age. Breastfed Cohort will be evaluated over the 16 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aussie Bubs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Validcare
- Responsible party
- Sponsor
- Investigators
- Keith Aqua, MD, Principal investigator, Backtee Holdings, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947084
- Sponsor's protocol ID
- BubsGMS_2023
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas. A 4 Month, Prospective, Randomized, Multi Center Clinical Trial.
- ClinicalTrials.gov ID
- NCT05947084
- Acronym / sponsor ID
- BubsGMS_2023
- Conditions
- Infant Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Aussie Bubs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Validcare
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 19 Apr 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 Jul 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.
A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.
Detailed description
A Growth Monitoring Study conducted according to FDA established guidelines to evaluate the test infant formulas ability to promote normal growth and development.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomization and exclusive feeding of study formulas by 14 days of age. Breastfed Cohort will be evaluated over the 16 weeks.
| Arm | Type | Receives |
|---|---|---|
| Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula | Experimental | Other: Infant FormulaInfant formula meets all nutrient requirements of the FDA. |
| Study Formula 2_Goat Milk Infant Formula | Experimental | Other: Infant FormulaInfant Formula meets all nutrient requirements of the FDA. |
| Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein | Experimental | Other: Infant FormulaInfant Formula meets all nutrient requirements of the FDA. |
| Study Formula 4_USDA Organic iron fortified infant formula | Active comparator | Other: Infant FormulaInfant Formula meets all nutrient requirements of the FDA. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy Term Infant
Key exclusion criteria (1 listed)
- Any health condition that would negatively impact infant feeding and growth.
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 |
|---|---|---|
| Infant FormulaGrowth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period | Other | Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula, Study Formula 2_Goat Milk Infant Formula, Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein, Study Formula 4_USDA Organic iron fortified infant formula |
Primary outcome
Weight gain (g) from study entry to 16 weeks of study.
Time frame: 16 weeks of Clinical Study
Growth Monitoring Study
3 secondary outcomes
Recumbent length gain (cm) from study entry to 16 weeks of study.
Time frame: 16 weeks of Clinical Study
Head Circumference gain (cm) from study entry to 16 weeks of study
Time frame: 16 weeks of Clinical Study
Tolerance of study formulas over 16 weeks of study
Time frame: 16 weeks of Clinical Study
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 2 Jul 2025.
- 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.
Keith Aqua, MD principal investigator
Backtee Holdings, LLC
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula in people with Infant Development, run by Aussie Bubs, Inc. at 29 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 1 inclusion and 1 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 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 (g) from study entry to 16 weeks of study. (time frame: 16 weeks of Clinical Study). 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 2 Jul 2025.