Infant Formula Study With Pre- And Postbiotics

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.

Study Overview

• Status: Completed
• Conditions: Infants; Formula Milk
• Intervention / Treatment: Other: Infant Formula

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Atlantia Food Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. Parent's or legal guardian's aged 18 years, written informed consent.
2. Infants exclusively formula fed at enrolment and parents/legal guardians have autonomously decided to exclusively formula feed until the end of intervention.
3. Infants aged 0 to 6 weeks (day 0 to day 42 inclusive).
4. 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.
5. Birth weight between 2.5 - 4.5 kg (within normal range for gestational age and sex, according to WHO definitions).
6. 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:

1. 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.
2. Infants with established or suspected cows' milk allergy, lactose intolerance, galactosaemia, or infants on a prescribed fibre-free (e.g., prebiotic oligosaccharides) diet.
3. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
4. Investigator's uncertainty about the willingness or ability of the parents/legal guardians to comply with the protocol requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infant formula; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.	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.	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	24 weeks

Collaborators and Investigators

• Sponsor: Nutricia UK Ltd
• Collaborators: University College Cork; Atlantia Food Clinical Trials; Teagasc; Danone Global Research & Innovation Center
• Investigators: Principal Investigator: Catherine Stanton, Teagasc

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: July 23, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Infants; Gut microbiome; Formula milk
• Additional Relevant MeSH Terms: Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Foods, Specialized; Milk Substitutes; Food, Formulated; Infant Food; Infant Formula
• Other Study ID Numbers: AFCRO-123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No