HealthyNCT03493711
Differences Between Breastfed and Formula Fed Infants
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
This study will help us learn how a child's diet affects growth and development. Read more about this study
- Who is it for?
- Ages 2 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2018to 6 Aug 2024
- Phase
- Observational
- 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 2 to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants
Who may be able to join
- Exclusive breast feeding or cow milk formula feeding during the first 3 months of life.
- For formula feeders, exclusively on Similac Advance Formula for at least 1 month prior to visit
- Age 2.5-3.5 months
Who cannot join
- Infants born to mother with preexisting medical conditions.
- Infants born to mother with medications during pregnancy known to influence fetal growth.
- Infants born to smoking, alcohol drinking or drug use mothers during pregnancy.
- Preterm
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: Microbiota Differences Between Breastfed and Formula Fed Infants
This study will help us learn how a child's diet affects growth and development.
Read the detailed description
This study will see how infants diet affects their growth and development. Up to 170 infants will be enrolled for one visit.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Fed | Exclusively breastfed for first 3 months of life | |
| Milk-based formula fed | Exclusively on Similac Advance Formula for at least 1 month prior to visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
The role of microbiota in gut
Stool samples will be collected
Measured: 2.5-3 months
The role of microbiota in immune system development
Stool samples will be collected
Measured: 2.5-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start21 Feb 2018
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aline Andres, PhD, RD, Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493711
- Sponsor's protocol ID
- 217562
- Status last verified
- Sep 2026
- First submitted
- 12 Feb 2018
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We did not obtain consent from participants to do so.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota Differences Between Breastfed and Formula Fed Infants
- ClinicalTrials.gov ID
- NCT03493711
- Acronym / sponsor ID
- 217562
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 10 Apr 2018 (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 help us learn how a child's diet affects growth and development.
Detailed description
This study will see how infants diet affects their growth and development. Up to 170 infants will be enrolled for one visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Fed | – | –Exclusively breastfed for first 3 months of life |
| Milk-based formula fed | – | –Exclusively on Similac Advance Formula for at least 1 month prior to visit |
Who may qualify
- Ages
- 2 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants
Key inclusion criteria (3 listed)
- Exclusive breast feeding or cow milk formula feeding during the first 3 months of life.
- For formula feeders, exclusively on Similac Advance Formula for at least 1 month prior to visit
- Age 2.5-3.5 months
Key exclusion criteria (4 listed)
- Infants born to mother with preexisting medical conditions.
- Infants born to mother with medications during pregnancy known to influence fetal growth.
- Infants born to smoking, alcohol drinking or drug use mothers during pregnancy.
- Preterm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The role of microbiota in gut
Time frame: 2.5-3 months
Stool samples will be collected
The role of microbiota in immune system development
Time frame: 2.5-3 months
Stool samples will be collected
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 25 Sep 2026.
- Individual participant dataSharing planned: No. We did not obtain consent from participants to do so.
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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.
Aline Andres, PhD, RD principal investigator
Arkansas Children's Nutrition Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute 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 3 inclusion and 4 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 25 Sep 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?
The role of microbiota in gut (time frame: 2.5-3 months). The study lists 2 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 25 Sep 2026.