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Can a palm oil free formula with prebiotics and postbiotics ease babies' digestion?

NCT ID NCT07734532

Symptom relief Sponsor: Nutricia UK Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study is testing whether a palm oil free infant formula that contains prebiotics and postbiotics (beneficial compounds from fermentation) is gentle on the digestive system and safe for healthy, full-term babies. Thirty infants, exclusively formula-fed from birth to 6 weeks old, will receive the formula as their only food for 24 weeks. Researchers will track stool patterns, growth, quality of life, and gut microbiome development to see how well the formula is tolerated.

What this could mean

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

Active substance
a palm oil free infant formula containing prebiotics and postbiotics derived from fermentation
What this could lead to
If well tolerated, this formula could offer a gentler option for formula-fed infants, potentially reducing digestive discomfort.
What could go wrong
This is a small, single-arm study with only 30 infants, so results may not apply to all babies. No serious risks are expected, but individual tolerance may vary.

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

30 people

The number who actually took part.

Started

Jun 2021

Finished

Oct 2023

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

Up to 6 weeks

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: 1. Parent's or legal guardian's aged 18 years, written informed consent. 2. Infants exclusively formula fed at enrolment and parents/legal guardians have autonomously decided to exclusively formula feed until the end of intervention. 3. Infants aged 0 to 6 weeks (day 0 to day 42 inclusive). 4. Healthy term singleton infants, gestational age \~ 37 and \< 42 weeks (i.e.,\~ 41 weeks+ 6 days). Healthy is defined as no supervision or medical treatment by a medical specialist. 5. Birth weight between 2.5 - 4.5 kg (within normal range for gestational age and sex, according to WHO definitions). 6. Willing to continue using the infant formula, during the study, not switching of formula, except for medical purposes in which case the infant would be excluded. Exclusion criteria: 1. Infants with congenital condition and/or previous or current illness and (or) medication use that could interfere with the study, in the opinion of the medical doctor. 2. Infants with established or suspected cows' milk allergy, lactose intolerance, galactosaemia, or infants on a prescribed fibre-free (e.g., prebiotic oligosaccharides) diet. 3. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. 4. Investigator's uncertainty about the willingness or ability of the parents/legal guardians to comply with the protocol requirements.

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As listed by the trial registrant

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

Formula milk Infants

Contacts and locations

Locations

  • Atlantia Food Clinical Trials

    Cork, Ireland

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