Infant DevelopmentNCT06059209
Enfamil NeuroPro Study
A study testing Enfamil NeuroPro and Enfamil Infant in people with Infant Development and Infant ALL, run by University of Arizona at 1 site in United States.
Trial summary
This study will compare infant gut bacteria for infants who have been fed a standard infant formula (Enfamil Infant); infants who have been fed a new infant formula designed to be more similar to breast milk (Enfamil NeuroPro); and breastfed infants. Read more about this study
- Who is it for?
- Ages 0 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development, Infant ALL
- What is being tested?
- Enfamil NeuroPro and Enfamil Infant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants with parental consent
- Parents are able to provide informed consent; own a smart phone and are able to fill out weekly digital questionnaires.
Who cannot join
- Prematurity (<= 36 weeks gestational age)
- Babies born through c-section
- Any health issues identified at the first postpartum screening
- Use of both breast milk and formula
- Use of donor breast milk
- Parent unwillingness/inability to avoid giving prebiotics, probiotics, symbiotics, and immune-stimulating products to the child for the duration of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Milk Fat Globule Membrane and 2'-Fucosyllactose in the Infant Gut Microbiota
This study will compare infant gut bacteria for infants who have been fed a standard infant formula (Enfamil Infant); infants who have been fed a new infant formula designed to be more similar to breast milk (Enfamil NeuroPro); and breastfed infants. These formulas are currently available on the market and meet FDA requirements for infant formula.
Read the detailed description
This study is a randomized, double-blind, parallel-group study comparing breast milk to Enfamil Infant and Enfamil NeuroPro formulas. The central hypothesis of the study is that the addition of milk fat globule membrane and2'-Fucosyllactose (2'-FL) to infant formula plays a role in shaping the microbiota in a manner similar to the microbiota of breastfed infants. To test this hypothesis, the investigators will explore longitudinal changes in the fecal microbiome from birth to 4 months of age in infants fed breast-milk, standard Enfamil Infant formula or Enfamil NeuroPro formula. Fecal samples will be collected at birth, and then monthly for 4 months. At the time of last collection one serum sample will be collected. The investigators will analyze basic growth parameters, fecal microbial community analysis by metagenomics, fecal metabolome by untargeted metabolomic analysis, and fecal and systemic indicators of inflammation and intestinal barrier function.
- Conditions
- Infant Development, Infant ALL
- Being tested
- Enfamil NeuroPro, Enfamil Infant
- Keywords
- Healthy Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enfamil NeuroProDietary supplement
FDA Infant formula
Enfamil InfantDietary supplement
FDA Infant formula
| Study group | Role | What they receive |
|---|---|---|
| Breast Milk | No intervention | Not described |
| Enfamil Infant | Other | Not described Receives: Dietary Supplement: Enfamil Infant |
| Enfamil NeuroPro | Active comparator | Not described Receives: Dietary Supplement: Enfamil NeuroPro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in microbial DNA in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.
Assessed using 16S amplicon profiling of stool samples
Measured: Birth to 4 months
Change from baseline in the gut metagenomics in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.
Samples sequenced using the NextSeq 500/550 and mapped against functional reference sequence databases using Bowtie2
Measured: Birth to 4 months
Change from baseline of metabolome in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.
Untargeted analysis by automated comparison of the ion features in the experimental samples to a reference library of chemical standard entries.
Measured: Birth to 4 months
Secondary outcomes (3)
Growth- Height
Measured periodically in centimeters as part of routine care
Measured: Birth to 4 months
Growth- Head circumference
Measured periodically in centimeters as part of routine care
Measured: Birth to 4 months
Growth- Weight
Measured periodically in kg as part of routine care
Measured: Birth to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start5 Jan 2023
- Primary completion26 Aug 2025
- Study completion31 May 2026 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be able to choose between the breast-fed or formula-fed group. Subjects in the formula-fed group will be randomly assigned to one of the two formulas, with a 50% chance of being assigned to each group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059209
- Sponsor's protocol ID
- STUDY00000917
- Status last verified
- Dec 2025
- First submitted
- 30 Aug 2023
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data and specimens will not be stored for future research.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Milk Fat Globule Membrane and 2'-Fucosyllactose in the Infant Gut Microbiota
- ClinicalTrials.gov ID
- NCT06059209
- Acronym / sponsor ID
- STUDY00000917
- Conditions
- Infant Development, Infant ALL
- Keywords
- Healthy Infants
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 28 Sep 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.
This study will compare infant gut bacteria for infants who have been fed a standard infant formula (Enfamil Infant); infants who have been fed a new infant formula designed to be more similar to breast milk (Enfamil NeuroPro); and breastfed infants. These formulas are currently available on the market and meet FDA requirements for infant formula.
Detailed description
This study is a randomized, double-blind, parallel-group study comparing breast milk to Enfamil Infant and Enfamil NeuroPro formulas. The central hypothesis of the study is that the addition of milk fat globule membrane and2'-Fucosyllactose (2'-FL) to infant formula plays a role in shaping the microbiota in a manner similar to the microbiota of breastfed infants. To test this hypothesis, the investigators will explore longitudinal changes in the fecal microbiome from birth to 4 months of age in infants fed breast-milk, standard Enfamil Infant formula or Enfamil NeuroPro formula. Fecal samples will be collected at birth, and then monthly for 4 months. At the time of last collection one serum sample will be collected. The investigators will analyze basic growth parameters, fecal microbial community analysis by metagenomics, fecal metabolome by untargeted metabolomic analysis, and fecal and systemic indicators of inflammation and intestinal barrier function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Subjects will be able to choose between the breast-fed or formula-fed group. Subjects in the formula-fed group will be randomly assigned to one of the two formulas, with a 50% chance of being assigned to each group.
| Arm | Type | Receives |
|---|---|---|
| Breast Milk | No intervention | – |
| Enfamil Infant | Other | Dietary Supplement: Enfamil Infant |
| Enfamil NeuroPro | Active comparator | Dietary Supplement: Enfamil NeuroPro |
Who may qualify
- Ages
- 0 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy term infants with parental consent
- Parents are able to provide informed consent; own a smart phone and are able to fill out weekly digital questionnaires.
Key exclusion criteria (6 listed)
- Prematurity (<= 36 weeks gestational age)
- Babies born through c-section
- Any health issues identified at the first postpartum screening
- Use of both breast milk and formula
- Use of donor breast milk
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 |
|---|---|---|
| Enfamil NeuroProFDA Infant formula | Dietary supplement | Enfamil NeuroPro |
| Enfamil InfantFDA Infant formula | Dietary supplement | Enfamil Infant |
Primary outcome
Change from baseline in microbial DNA in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.
Time frame: Birth to 4 months
Assessed using 16S amplicon profiling of stool samples
Change from baseline in the gut metagenomics in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.
Time frame: Birth to 4 months
Samples sequenced using the NextSeq 500/550 and mapped against functional reference sequence databases using Bowtie2
Change from baseline of metabolome in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.
Time frame: Birth to 4 months
Untargeted analysis by automated comparison of the ion features in the experimental samples to a reference library of chemical standard entries.
3 secondary outcomes
Growth- Height
Time frame: Birth to 4 months
Growth- Head circumference
Time frame: Birth to 4 months
Growth- Weight
Time frame: Birth to 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No. Data and specimens will not be stored for future research.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enfamil NeuroPro and Enfamil Infant in people with Infant Development and Infant ALL, run by University of Arizona 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 2 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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in microbial DNA in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk. (time frame: Birth to 4 months). The study lists 3 primary outcomes in all. 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 11 Dec 2025.