Formula MilkNCT07734532
Infant Formula Study With Pre- And Postbiotics
A study testing Infant Formula in people with Formula Milk and Infants, run by Nutricia UK Ltd at 1 site in Ireland.
Trial summary
This prospective, single-arm study evaluates the gastrointestinal tolerance, safety, and growth, quality of life and gut microbiome development of healthy term infants fed a commercially available palm oil free infant formula containing prebiotics and postbiotics derived from fermentation over a 24-week period. Read more about this study
- Who is it for?
- Ages Up to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Formula Milk, Infants
- What is being tested?
- Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 17 Jun 2021to 18 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent's or legal guardian's aged 18 years, written informed consent.
- Infants exclusively formula fed at enrolment and parents/legal guardians have autonomously decided to exclusively formula feed until the end of intervention.
- Infants aged 0 to 6 weeks (day 0 to day 42 inclusive).
- 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.
- Birth weight between 2.5 - 4.5 kg (within normal range for gestational age and sex, according to WHO definitions).
- 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.
Who cannot join
- 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.
- Infants with established or suspected cows' milk allergy, lactose intolerance, galactosaemia, or infants on a prescribed fibre-free (e.g., prebiotic oligosaccharides) diet.
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Investigator's uncertainty about the willingness or ability of the parents/legal guardians to comply with the protocol requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastrointestinal Tolerance, Safety And Acceptability In Infants Consuming Palm Oil Free Infant Formula Containing Prebiotics And Postbiotics
This prospective, single-arm study evaluates the gastrointestinal tolerance, safety, and growth, quality of life and gut microbiome development of healthy term infants fed a commercially available palm oil free infant formula containing prebiotics and postbiotics derived from fermentation over a 24-week period. Infants aged 0 to 6 weeks who were exclusively formula-fed at enrolment received the study formula as their sole source of nutrition. The primary objective is to assess gastrointestinal tolerance and safety. Secondary objectives include assessment of infant quality of life, parental experience and to characterise the development of the infant gut microbiome. The study includes four visits over 24 weeks, during which clinical measurements, safety assessments, and sample collection are performed.
- Conditions
- Formula Milk, Infants
- Being tested
- Infant Formula
- Keywords
- Infants, Gut microbiome, Formula milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant FormulaOther
Cow's milk based infant formula with with prebiotics and postbiotics derived from fermentation
| Study group | Role | What they receive |
|---|---|---|
| Infant formula | Experimental | 24-weeks consumption of cow's milk based palm oil free infant formula with prebiotics and postbiotics derived from fermentation Receives: Other: Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Tolerance - Stool consistency and frequency
Gastrointestinal tolerance evaluated with stool consistency and stool frequency for 3 consecutive days after first intake of study product and before each visit at week 2, week 10, and week 24 of intervention.
Measured: 24 weeks
Gastrointestinal Tolerance - Pediatric Quality of Life Inventory (PedsQL)
Scores are transformed to a 0 to 100 scale, with higher scores indicating better health-related quality of life and fewer problems. PedsQL to assess infant's quality of life at baseline and week 2, week 10, and week 24.
Measured: 24 weeks
Gastrointestinal Tolerance - Infant Gastrointestinal Symptom Questionnaire (IGSQ-13)
The IGSQ-13 consists of 13 items with a total score ranging from 13 to 65, where lower scores indicate better gastrointestinal tolerance and fewer symptoms, and higher scores indicate greater gastrointestinal distress. IGSQ-13 questionnaire to asses gastrointestinal tolerance at baseline and week 2, week 10, and week 24.
Measured: 24 weeks
Safety - Growth (Weight)
Safety parameters included weight gain measured at baseline, week 2, week 10, and week 24 of intervention.
Measured: 24 weeks
Safety - Growth (Length)
Safety parameters included length gain measured at baseline, week 2, week 10, and week 24 of intervention.
Measured: 24 weeks
Safety - Growth (Head circumference)
Safety parameters included head circumference measured at baseline, week 2, week 10, and week 24 of intervention.
Measured: 24 weeks
Safety - Adverse Events
Occurrence of (serious) AE measured throughout the intervention period.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start17 Jun 2021
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Formula MilkStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, Teagasc, University College Cork, Danone Global Research & Innovation Center
- Responsible party
- Sponsor
- Investigators
- Catherine Stanton, Principal investigator, Teagasc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734532
- Sponsor's protocol ID
- AFCRO-123
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Tolerance, Safety And Acceptability In Infants Consuming Palm Oil Free Infant Formula Containing Prebiotics And Postbiotics
- ClinicalTrials.gov ID
- NCT07734532
- Acronym / sponsor ID
- AFCRO-123
- Conditions
- Formula Milk, Infants
- Keywords
- Infants, Gut microbiome, Formula milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, Teagasc, University College Cork, Danone Global Research & Innovation Center
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, single-arm study evaluates the gastrointestinal tolerance, safety, and growth, quality of life and gut microbiome development of healthy term infants fed a commercially available palm oil free infant formula containing prebiotics and postbiotics derived from fermentation over a 24-week period. Infants aged 0 to 6 weeks who were exclusively formula-fed at enrolment received the study formula as their sole source of nutrition. The primary objective is to assess gastrointestinal tolerance and safety. Secondary objectives include assessment of infant quality of life, parental experience and to characterise the development of the infant gut microbiome. The study includes four visits over 24 weeks, during which clinical measurements, safety assessments, and sample collection are performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant formula | Experimental | Other: Infant Formula24-weeks consumption of cow's milk based palm oil free infant formula with prebiotics and postbiotics derived from fermentation |
Who may qualify
- Ages
- Up to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parent's or legal guardian's aged 18 years, written informed consent.
- Infants exclusively formula fed at enrolment and parents/legal guardians have autonomously decided to exclusively formula feed until the end of intervention.
- Infants aged 0 to 6 weeks (day 0 to day 42 inclusive).
- 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.
- Birth weight between 2.5 - 4.5 kg (within normal range for gestational age and sex, according to WHO definitions).
Key exclusion criteria (4 listed)
- 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.
- Infants with established or suspected cows' milk allergy, lactose intolerance, galactosaemia, or infants on a prescribed fibre-free (e.g., prebiotic oligosaccharides) diet.
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Investigator's uncertainty about the willingness or ability of the parents/legal guardians to comply with the protocol requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant FormulaCow's milk based infant formula with with prebiotics and postbiotics derived from fermentation | Other | Infant formula |
Primary outcome
Gastrointestinal Tolerance - Stool consistency and frequency
Time frame: 24 weeks
Gastrointestinal tolerance evaluated with stool consistency and stool frequency for 3 consecutive days after first intake of study product and before each visit at week 2, week 10, and week 24 of intervention.
Gastrointestinal Tolerance - Pediatric Quality of Life Inventory (PedsQL)
Time frame: 24 weeks
Scores are transformed to a 0 to 100 scale, with higher scores indicating better health-related quality of life and fewer problems. PedsQL to assess infant's quality of life at baseline and week 2, week 10, and week 24.
Gastrointestinal Tolerance - Infant Gastrointestinal Symptom Questionnaire (IGSQ-13)
Time frame: 24 weeks
The IGSQ-13 consists of 13 items with a total score ranging from 13 to 65, where lower scores indicate better gastrointestinal tolerance and fewer symptoms, and higher scores indicate greater gastrointestinal distress. IGSQ-13 questionnaire to asses gastrointestinal tolerance at baseline and week 2, week 10, and week 24.
Safety - Growth (Weight)
Time frame: 24 weeks
Safety parameters included weight gain measured at baseline, week 2, week 10, and week 24 of intervention.
Safety - Growth (Length)
Time frame: 24 weeks
Safety parameters included length gain measured at baseline, week 2, week 10, and week 24 of intervention.
Safety - Growth (Head circumference)
Time frame: 24 weeks
Safety parameters included head circumference measured at baseline, week 2, week 10, and week 24 of intervention.
Safety - Adverse Events
Time frame: 24 weeks
Occurrence of (serious) AE measured throughout the intervention period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Stanton principal investigator
Teagasc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula in people with Formula Milk and Infants, run by Nutricia UK Ltd at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Tolerance - Stool consistency and frequency (time frame: 24 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.