Symbiotic & Colonization

Nestlé

Status and phase

Completed

Phase 2

Conditions

Healthy

Treatments

Other: Breastfeeding

Dietary Supplement: Infant formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT01983072

06.08.INF

Details and patient eligibility

About

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.

Full 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.

Enrollment

141 patients

Sex

All

Ages

Under 4 months old

Volunteers

Accepts Healthy Volunteers

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