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Baby's first food may shape gut bacteria for life

NCT ID NCT03493711

Knowledge-focused Sponsor: Arkansas Children's Hospital Research Institute Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
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Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers at Arkansas Children's Hospital are studying how a baby's diet affects the bacteria living in the gut and how the immune system develops. They are enrolling 158 healthy infants aged 2.5 to 3.5 months who were either exclusively breastfed or fed Similac Advance formula. The team collects stool samples to compare the types and amounts of gut bacteria between the two groups. The goal is to understand whether early feeding choices influence growth and immune development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If researchers find clear differences in gut bacteria between feeding groups, this could shape advice on infant nutrition and point toward ways to support immune development in babies who cannot breastfeed.
What could go wrong
This is an observational study, so it can show links between diet and gut bacteria but cannot prove cause and effect. Many factors beyond feeding, such as genetics and home environment, also shape an infant's microbiome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

158 people

The number who actually took part.

Started

Feb 2018

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Infants

Ages

2 to 3 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

Contacts and locations

Locations

  • Arkansas Children's Nutrition Center

    Little Rock, Arkansas, 72202, United States

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