Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05783141
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-02-21
Brief Title:
Prebiotic Effects in Healthy Toddlers
Sponsor:
Beneo-Institute
Organization:
Beneo-Institute
Study Overview
Official Title:
Double-blind Randomized Placebo-controlled Trial Investigating Cumulative or Even Synergistic Effects of a Novel Prebiotic Combination in Healthy Toddlers
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PrebiKidz
Brief 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 SCFAThe efficacy of the prebiotic combination to improve toddlers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None