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COMPLETED
NCT07734532
NA

Infant Formula Study With Pre- And Postbiotics

Sponsor: Nutricia UK Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - 6 Weeks

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2021-06-17

Completion Date

2023-10-18

Last Updated

2026-08-28

Healthy Volunteers

Yes

Interventions

OTHER

Infant Formula

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

Locations (1)

Atlantia Food Clinical Trials

Cork, Ireland