The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of Bifidobacteria species in comparison with a formula non-supplemented with pre and probiotics.
The infants will be recruited and randomized between 0 and 14 days. The intervention period, in terms of data necessary for the primary outcome, will be until they reach 3 months old. Measurements will be collected on three separate occasions during this period, i.e. 2 and 6 weeks and 3 months. Stools will be collected, on 3 separate occasions, i.e. 4-5 day, 6 weeks and 3 months of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
141
Breastfeeding
Hôpital Saint Joseph
Marseille, France
Hôpital de la Conception
Marseille, France
Hôpital Nord
Marseille, France
The Medical University of Warsaw
Warsaw, Poland
stool bacterial populations
(Lactobacilli, Clostridia, Bacteroides, bifidobacteria, staphylococci, Enterobacteria and Bifidobacterial species at 1.5 months and 3 months of age of the infants.
Time frame: 3 months
changes in weight
weight
Time frame: 3 months
Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
Time frame: 3 months
changes in length
changes in length
Time frame: 3 months
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