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Baby formula with 'Good Bacteria' under the microscope: new study seeks answers

NCT ID NCT07207109

Knowledge-focused Sponsor: Nutricia Research 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study looks at how a special follow-on formula with added good bacteria (synbiotics) affects the gut bacteria of healthy babies aged 6 to 9 months. Over 12 weeks, parents will feed their baby either the test formula or a regular one, collect stool samples, and keep a diary. The goal is to see if the formula changes the balance of gut bacteria and supports healthy digestion.

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

About 268 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jun 2027

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.

Ages

6 to 9 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: 1. Healthy infants as per the clinical judgement of the Investigator 2. Singleton infants 3. Infants ≥6 months and ≤9 months of age at Visit 1 4. Infant's weight-for-age WHO z-score within ± 2 SD at Visit 1 5. Infants fed with an infant or follow-on formula at Visit 1. 6. Infants are familiar with, and are expected to drink, ≥600 mL formula per day. 7. Written informed consent (IC) from parent(s) and/or legally acceptable representative(s) aged ≥18 years at Visit 1. Exclusion Criteria: 1. Infants with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances 2. Infants who received breastfeeding ≤14 days before Visit 1 3. Infants who are potty-trained 4. Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement. 5. Use of medication or nutritional products/food supplements known to impact the study outcomes ≤14 days before Visit 1 or expected need during the study. 6. Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products. 7. Incapability of infants' parents and/or legally acceptable representative(s) to comply with study protocol as per the judgement of the investigator or investigator's uncertainty about the willingness or ability of parents legally acceptable representative(s) to comply with the protocol requirements, including access to a phone. 8. Children of employees and/or family members or relatives of employees of Danone, the participating sites, or any other nutrition company that develops infant, follow-on or young child formulae.

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As listed by the trial registrant

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

FAECES Follow-on formula Gut microbiota Infant

Contacts and locations

Locations

  • DPS_RSUP Prof. Dr. I.G.N.G. Ngoerah

    Denpasar, Bali, Indonesia

  • SBY_RSUD Dr. Soetomo

    Surabaya, East Java, Indonesia

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