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Infant stool samples could reveal what a healthy baby gut looks like

NCT ID NCT05472688

Knowledge-focused Sponsor: Persephone Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

My Baby Biome is an observational study that collects stool samples from infants between 2 weeks and 2 months old to map the bacteria, proteins, and other molecules present in a healthy gut. Parents also complete questionnaires about their baby's immune health. Researchers analyze the samples to find biomarkers linked to healthy infants, with the goal of using that information to develop precision probiotics and live biotherapeutic products for infant gut health.

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 identify reliable markers of a healthy infant gut, that knowledge could guide the design of precision probiotics and live biotherapeutic products aimed at improving gut health in babies.
What could go wrong
This is an observational study, so it cannot prove that any bacterium or protein causes health or disease. The findings may not generalize beyond the specific group of infants enrolled, and any future probiotic products would still need separate testing.

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

430 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

It is anticipated that 600 infants will enroll in this study. It is preferred that enrollment is balanced by sex; however, it is not required. All efforts will be made to provide racial/ethnic balance, with a goal of 20% African American and 10% each of patients with Asian or Hispanic descent. Additionally, we will look to maintain a demographic that represents different birth and feeding modes.

Ages

0 to 2 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.

Exclusion Criteria: * Infants under 2 weeks or over 2 months old * Infants given any antibiotic or probiotic treatments * Infants delivered prematurely or admitted to the NICU outside of establishment of normal feeding * Infants with mothers under the age of 18 * Infants with mothers known to have HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV2

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Conditions

The condition(s) this trial relates to.

Dysbiosis

As listed by the trial registrant

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

Dysbiosis

Contacts and locations

Locations

  • Persephone Biosciences, Inc.

    San Diego, California, 92121, United States

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Other studies related to the condition(s) this trial covers.