This survey is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance, gut health, fecal flora and immune function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
392
GOS resource (β-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3)
Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)
Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)
Anthropometric parameters
body length, body weight, and head circumferences at enrollment (15± 3 days of age), 30, 60, 90, 120, 150 and 180 days of age
Time frame: 6 months
Fecal bacteria analysis
o Fecal bacteria analysis of Bifidobacterium, Lactobacillus, Clostridium perfringens and Escherichia coli at the enrollment 30 days of age ,120 days of age and 180 days of age
Time frame: 6 months
Dietary
tool characteristics, tolerance, formula acceptance, stress and 3-day well-being (quality of life) questionnaire prior to each survey visit recorded at 30, 60, 90, 120, 150 and 180 days of age
Time frame: 6 months
Formula intake
Formula intake (24-hour dietary recall) at 30, 60, 90, 120, 150 and 180 days of age
Time frame: 6 months
All medically confirmed adverse events and antibiotic record
All medically confirmed adverse events including crying, gaseous colics, regurgitation, vomit, skin rashes, fever and concomitant medications recorded on medical records as a measure of safety and tolerability throughout the survey period.
Time frame: 6 months
Fecal sIgA and SCFA analysis
Fecal sIgA and SCFA analysis at 30 days of age (visit 1) and 180 days of age (visit 6)
Time frame: 6 months
Saliva cortisol, IgA, chromogranin A and lysozyme
Saliva cortisol, IgA, chromogranin A and lysozyme at 30, 90 and 180 days of age
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exclusively breastfed infants for at least 7 days prior to enrollment
Time frame: 6 months