Symbiotic & Colonization

Study Overview
=================
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.

Official Title
-----------------
Effect of Starter Formula With Symbiotic on Microbiota Balance

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Infant formula
* Other: Breastfeeding


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 4 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infant starter formula<br>standard infant formula | Dietary Supplement: Infant formula<br> <br> |
| Experimental: Infant starter formula + prebiotics + probiotics<br>infant formula | Dietary Supplement: Infant formula<br> <br> |
| Other: Breastfeeding group<br>reference group | Other: Breastfeeding<br>* Breastfeeding<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stool bacterial populations | (Lactobacilli, Clostridia, Bacteroides, bifidobacteria, staphylococci, Enterobacteria and Bifidobacterial species at 1.5 months and 3 months of age of the infants. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in weight | weight | 3 months | 
| Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic) | Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic) | 3 months | 
| changes in length | changes in length | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonization of the gastrointestinal tract with bacteria