NCT04441359

Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula

Effects of the Supplementation With Oligosaccharides on the Prevention of Infections in Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Beneo-Institute · Industry
• Sex: All
• Age: 1 Day – 4 Months
• Healthy volunteers: Accepted

Summary

The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.

Detailed description

The study primarily aimed to evaluate the effects of long-term supplementation of an infant formula with a mixture of short and long chain inulin-type oligosaccharides on immunological-health related outcomes, as well as on gastrointestinal function and well-being in infants during the first year of life. Effects on infant growth, tolerance and on the composition of fecal microbiota were further objectives of this study. The study was conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy term infants. The two groups of the study are product group (standard infant formula supplemented with inulin-type fructans) and control group (non-supplemented standard infant formula).

Conditions

• Infection
• Microbial Colonization
• Healthy

Interventions

Type	Name	Description
OTHER	Supplemented formula	standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans
OTHER	Standard formula	standard infant formula not supplemented with prebiotic inulin-type fructans

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-10-31
• Completion: 2010-10-31
• First posted: 2020-06-22
• Last updated: 2020-06-22

Locations

8 sites across 2 countries: Belgium, Spain