The purpose of this study is to determine whether an infant formula supplemented with a new probiotic CECT7210, is effective in reducing the incidence of infections, specially the gastrointestinal ones.
This a multicenter, controlled, randomized, prospective, parallel, double-blinded study to evaluate the effect of an infant formula containing a new probiotic, Bifidobacterium longum biovar infantis CECT7210, on the incidence of diarrhea in healthy infants born at term. Infants will be randomized to take an standard infant formula or the infant formula with the probiotic CECT7210 during 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
194
Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.
Standard formula without probiotics
Hospital Sant Joan de Reus
Reus, Tarragona, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Joan XXIII
Tarragona, Spain
Changes in diarrhea incidence
Differences between diarrhea incidence amongst groups from baseline to 12th weeks.
Time frame: At 4th, 8th, 12th weeks
Changes in infections incidence
Differences between rate of infections or duration amongst groups.
Time frame: At 4th, 8th, 12th weeks.
Changes in microbiota
Differences between faecal bacterial populations.
Time frame: At 4th, 8th, 12th weeks
Changes in Immunoglobulin A secretor (IgAs)
Differences between faecal IgAs amongst groups.
Time frame: At 4th and 12th weeks
Tolerability of the product
To evaluate gastrointestinal tolerability of both study formulas.
Time frame: At 4th, 8th and 12th weeks
Growth
To compare anthropometric measurements between probiotic CECT7210 formula group and standard group.
Time frame: At 4th, 8th and 12th weeks
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