Clinical trial NCT01983072: Symbiotic & Colonization
Official title: Effect of Starter Formula With Symbiotic on Microbiota Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: colonization of the gastrointestinal tract with bacteria
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 141
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: stool bacterial populations
timeFrame: 3 months
Secondary outcomes:
measure: changes in weight
timeFrame: 3 months
measure: Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
timeFrame: 3 months
measure: changes in length
timeFrame: 3 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Marseille
country: France
facility: Hôpital de la Conception
city: Marseille
country: France
facility: Hôpital Nord
city: Warsaw
country: Poland
facility: The Medical University of Warsaw
Study officials:
affiliation: The Medical University of Warsaw
name: Hania Szajewska
role: PRINCIPAL_INVESTIGATOR
References: