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New organic baby formula put to the test: will babies grow as expected?

NCT ID NCT05783037

Knowledge-focused Sponsor: Bobbie Baby, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether healthy full-term babies fed a new organic cow's milk formula grow at the same rate as babies fed an existing formula. It also included a group of breastfed babies for comparison. About 394 infants participated, and researchers measured weight gain, length, and head circumference over time.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

394 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 2025

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.

Ages

0 to 11 days

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: * Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days) * Birth weight of ≥ 2,500 g and ≤ 4,500 g * Postnatal age ≤ 11 days at time of enrollment * Singleton * Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding) * Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, reporting of AEs, and urine collection) * Caregiver willing and able to sign IRB approved informed consent Exclusion Criteria: * Infant born with medical complications (e.g., neurological, cerebral palsy, etc.) * Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth * Maternal, fetal, or infant medical history thought to have an impact on growth and/or development (substance abuse, positive HIV status, opioid exposure, or diabetes requiring insulin) * Infant receiving prescription medication * Infant with a known history of cow's milk protein allergy, excluding lactose intolerance * Infant who has been treated with antibiotics or medications that may impact growth, GI tolerance and/or development * Infant or family history (grandparent, parent, sibling) with known folate metabolism disorder * Caregiver intent to feed non-study formula or solid food during the study

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Conditions

The condition(s) this trial relates to.

Body Weight Breast Feeding

As listed by the trial registrant

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

Healthy growth

Contacts and locations

Locations

  • SPRIM Pro

    Indian Harbour Beach, Florida, 32937, United States