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Infant Formula Study With Pre- And Postbiotics
Sponsor: Nutricia UK Ltd
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
Conditions
Interventions
Infant Formula
Cow's milk based infant formula with with prebiotics and postbiotics derived from fermentation
Locations (1)
Atlantia Food Clinical Trials
Cork, Ireland