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Infant Formula Study With Pre- And Postbiotics

NCT07734532 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-28

No results posted yet for this study

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

Interventions

OTHER

Infant Formula

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

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • Teagasc

    collaborator INDUSTRY

  • University College Cork

    collaborator OTHER

  • Danone Global Research & Innovation Center

    collaborator INDUSTRY

  • Nutricia UK Ltd

    lead INDUSTRY

Principal Investigators

  • Catherine Stanton · Teagasc

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
6 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2023-10-18
Completion
2023-10-18

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07734532 on ClinicalTrials.gov