Healthy
Conditions
Keywords
colonization of the gastrointestinal tract with bacteria
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTInfant formula
OTHERBreastfeeding
Breastfeeding
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy newborn infant * Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation) * Age of infant is between 14 days at the time of enrollment * Birth weight between 2500g and 4500g * For the Formula fed groups: The infant's mother has elected, before the 14th day of their child's life, not to continue breastfeeding (no breastfeeding after the 14th day of the child's life) For the Breastfed group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age * Having obtained his/her legal representative's informed consent
Exclusion criteria
* Congenital illness or malformation that may affect normal growth * Significant pre-natal and/or post-natal disease * Re-hospitalization for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study). * Newborn who have received antibiotics during the first 14 days of life * Receiving infant formula containing pro and/or prebiotics at the time of enrolment * Newborn whose parents / caregivers cannot be expected to comply with treatment * Newborn currently participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| stool bacterial populations | 3 months | (Lactobacilli, Clostridia, Bacteroides, bifidobacteria, staphylococci, Enterobacteria and Bifidobacterial species at 1.5 months and 3 months of age of the infants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in weight | 3 months | weight |
| Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic) | 3 months | Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic) |
| changes in length | 3 months | changes in length |
Countries
France, Poland
Outcome results
None listed