An interventional study of Infant Formula in Formula Milk and Infants, sponsored by Nutricia UK Ltd. Completed at 1 site in Ireland. Open to participants aged Up to 6 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Nutricia UK Ltd (part of Danone) · Not applicable, Interventional, and Basic science
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.
Nutricia UK Ltd is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
24-weeks consumption of cow's milk based palm oil free infant formula with prebiotics and postbiotics derived from fermentation
Other: Infant Formula
Cow's milk based infant formula with with prebiotics and postbiotics derived from fermentation
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.
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks
Safety - Growth (Weight)
Safety parameters included weight gain measured at baseline, week 2, week 10, and week 24 of intervention.
Time frame: 24 weeks
Safety - Growth (Length)
Safety parameters included length gain measured at baseline, week 2, week 10, and week 24 of intervention.
Time frame: 24 weeks
Safety - Growth (Head circumference)
Safety parameters included head circumference measured at baseline, week 2, week 10, and week 24 of intervention.
Time frame: 24 weeks
Safety - Adverse Events
Occurrence of (serious) AE measured throughout the intervention period.
Time frame: 24 weeks
Exploratory parameter - Gut Microbiota
Characterisation of the gut microbiota composition and functionality of infants consuming the study product at baseline and week 2, week 10, and week 24 using metagenomics and culturomics sequencing methods.
Time frame: 24 weeks
Exploratory parameter - Parent's Product Acceptability
To assess acceptability of the study product at baseline and week 2, week 10, and week 24 using a product evaluation questionnaire.
Time frame: 24 weeks
Exploratory parameter - Comparison with INFANTMET study
Comparison of gut microbiota composition and functionality with an external reference cohort of exclusively breastfed infants from the INFANTMET study.
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.