NCT05783141

Prebiotic Effects in Healthy Toddlers

Double-blind, Randomized Placebo-controlled Trial Investigating Cumulative or Even Synergistic Effects of a Novel Prebiotic Combination in Healthy Toddlers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 342 (estimated)
• Sponsor: Beneo-Institute · Industry
• Sex: All
• Age: 10 Months – 36 Months
• Healthy volunteers: Accepted

Summary

The aim of this study is to demonstrate that a dietary supplementation with a novel prebiotic combination is safe, well tolerated and able to improve overall health of toddlers.

Detailed description

The fermentation of a novel prebiotic combination leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA).The efficacy of the prebiotic combination to improve toddler's digestive function will be addressed. The overall health will be assessed as a measure of reduced number of febrile days resulting in less days of absenteeism from daycare centers.

Conditions

• Child Development
• Diet, Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	New prebiotic follow-on formula, randomly assigned to healthy toddlers	Standard follow-on formula administered orally
DIETARY_SUPPLEMENT	Standard follow-on formula, randomly assigned to healthy toddlers	Standard follow-on formula administered orally

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2023-03-24
• Last updated: 2024-09-19

Locations

1 site across 1 country: Belgium