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Completed

NCT Number: NCT07734532

Infant Formula Study With Pre- 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.

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Key information

Conditions

Formula Milk Infants

Age range

Up to 6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlantia Food Clinical Trials

Cork, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Infant Formula

Other

Cow's milk based infant formula with with prebiotics and postbiotics derived from fermentation

Primary outcomes

  1. 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.

  2. Gastrointestinal Tolerance - Pediatric Quality of Life Inventory (PedsQL)

    Time frame: 24 weeks

    PedsQL to assess infant's quality of life at baseline and week 2, week 10, and week 24.

  3. Gastrointestinal Tolerance - Infant Gastrointestinal Symptom Questionnaire (IGSQ-13)

    Time frame: 24 weeks

    IGSQ-13 questionnaire to asses gastrointestinal tolerance at baseline and week 2, week 10, and week 24.

  4. Safety - Growth (Weight)

    Time frame: 24 weeks

    Safety parameters included weight gain measured at baseline, week 2, week 10, and week 24 of intervention.

  5. Safety - Growth (Length)

    Time frame: 24 weeks

    Safety parameters included length gain measured at baseline, week 2, week 10, and week 24 of intervention.

  6. 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.

  7. Safety - Adverse Events

    Time frame: 24 weeks

    Occurrence of (serious) AE measured throughout the intervention period.

Other outcomes

  1. Exploratory parameter - Gut Microbiota

    Time frame: 24 weeks

    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.

  2. Exploratory parameter - Parent's Product Acceptability

    Time frame: 24 weeks

    To assess acceptability of the study product at baseline and week 2, week 10, and week 24 using a product evaluation questionnaire.

  3. Exploratory parameter - Comparison with INFANTMET study

    Time frame: 24 weeks

    Comparison of gut microbiota composition and functionality with an external reference cohort of exclusively breastfed infants from the INFANTMET study.

Sponsors and collaborators

Lead sponsor

Nutricia UK Ltd

Industry

Collaborators

  • Atlantia Food Clinical Trials
  • Danone Global Research & Innovation Center
  • Teagasc
  • University College Cork

Registry information

Official study title

Gastrointestinal Tolerance, Safety And Acceptability In Infants Consuming Palm Oil Free Infant Formula Containing Prebiotics And Postbiotics

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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