Infant Formula Study With Pre- And Postbiotics

NCT07734532 | Completed

• 1 other identifier: AFCRO-123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Infants; Gut microbiome; Formula milk

Outcome Measures

Primary Outcomes (7)

• 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.

  24 weeks

• Gastrointestinal Tolerance - PedsQL

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

  24 weeks

• Gastrointestinal Tolerance - IGSQ-13

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

  24 weeks

• Safety - Growth (Weight)

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

  24 weeks

• Safety - Growth (Length)

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

  24 weeks

• Safety - Growth (Head circumference)

  Safety parameters included head circumference measured at baseline, week 2, week 10, and week 24 of intervention.

  24 weeks

• Safety - Adverse Events

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

  24 weeks

Other Outcomes (3)

• Exploratory parameter - Gut Microbiota

  24 weeks

• Exploratory parameter - Parent's Product Acceptability

  24 weeks

• Exploratory parameter - Comparison with INFANTMET study

  24 weeks

Study Arms (1)

Infant formula

EXPERIMENTAL

24-weeks consumption of cow's milk based palm oil free infant formula with prebiotics and postbiotics derived from fermentation

Other: Infant Formula

Interventions

Infant Formula OTHER

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

Infant formula

Eligibility Criteria

• Age: Up to 6 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutricia UK Ltd: lead
• Atlantia Food Clinical Trials: collaborator
• Teagasc: collaborator
• University College Cork: collaborator
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Ireland

Location

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Officials

• Catherine Stanton

  Teagasc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 29, 2026
• Study Start: June 17, 2021
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)