This research study will compare the effect of test product #1 (containing a probiotic with the Galacto-OligoSaccharides fiber. GOS) and test product #2 (containing a probiotic without the GOS fiber) to understand how they can contribute to healthy digestion in toddlers between the age of 24 - 36 months. The hypothesis is that L. reuteri from TEST#1 will demonstrate an improved survival in the GIT of toddlers compared to that of TEST#2. This study is a single-centre, randomized, double-blind, comparator-controlled, parallel group study. The study will be conducted at the Clinical Innovation Lab (CIL) at Nestlé Research.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
25
Toddler milk with preconditioned L. reuteri and containing GOS
Toddler milk with standard/non-preconditioned L. reuteri and not containing GOS.
Société des Produits Nestlé S.A.
Lausanne, Canton of Vaud, Switzerland
Colony forming units of feces (CFU/g)
The primary end point is quantification of L. reuteri DSM 17938 in stool using quantitative polymerase chain reaction (qPCR).
Time frame: Baseline (visit Day 0), Day 2, Day 3, Day4, Day 5, Day6 Day 7 and D21
Gut microbiota
Diversity and functionality will be evaluated on at least 8 stools samples using shotgun metagenomic sequencing. Structure and prevalence of microbiota and evaluation of taxa and function in the survival of the probiotic.
Time frame: Between Day 0 and Day 21
Gastrointestinal (GI) tolerance and stooling patterns
Parent perceptions of GI symptoms and GI-related behaviors using Toddler Gut Comfort Questionnaire (GCQ) and stool frequency and consistency
Time frame: Between Day 0 and Day 21
Assessment of dietary variety
Dietary variety assessed using a parent-reported Food Frequency Questionnaire (FFQ)
Time frame: Between Day 0 and Day 21
Safety and tolerability
\- Adverse events type, incidence, severity, and relationship to TEST1 and TEST2 products.
Time frame: Between Day 0 and Day 21
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