Clinical Trial

Infant Formula Study With Pre- And Postbiotics

Completed
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.
Trial Details
NCT Number NCT07734532
Lead Sponsor Nutricia UK Ltd
Collaborators: Atlantia Food Clinical Trials, Teagasc, University College Cork, Danone Global Research & Innovation Center
Conditions Formula Milk, Infants
Enrollment 30 participants
Start Date 2021-06-17
Primary Completion 2023-10-18 (estimated)
Study Completion 2023-10-18 (estimated)
Updated on ClinicalTrials.gov 2026-07-29