Effect of Starter Formula on Infection Prevention

Study Overview
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Brief Summary
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The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.

Official Title
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Effect of Starter Formula With Synbiotics on Prevention of Gastro-intestinal Infections and All Infections With Fever in Full Term Infants

Conditions
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Gastro-intestinal Infections, Infections With Fever

Intervention / Treatment
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* Other: starter infant formula with pro and prebiotics
* Other: Placebo comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy newborn infant Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation) Age of infant is ≤ 13 days at the time of enrollment Birth weight ≥ 2500g and ≤ 4500g For the FF groups: The infant's mother has elected not to breastfeed For the BF 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 (especially immunodeficiencies) Significant pre-natal and/or post-natal diseases Perinatal antibiotic or infants on antibiotics at the time of inclusion Infants whose mother has had an acute infection during the last month of pregnancy Re-hospitalisation 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) Receiving infant formula containing probiotics and/or prebiotics at the time of enrollment Newborn whose parents / caregivers cannot be expected to comply with treatment Newborn currently participating in another interventional clinical trial

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Starter infant formula with pro and prebiotics<br>starter infant formula from enrollment till 6 months of age, followed by a commercially available Nestlé follow-up formula from 6 to 12 months of age | Other: starter infant formula with pro and prebiotics<br> <br> |
| Placebo Comparator: starter infant formula without pro and prebiotics<br>starter infant formula from enrollment till 6 months of age, followed by a commercially available Nestlé follow-up formula from 6 to 12 months of age | Other: Placebo comparator<br> <br> |
| No Intervention: Breastfeeding group<br>exclusively breastfeeding during the first 3 months of age, followed by a commercially available Nestlé starter infant formula from 4 to 6 months of age (if applicable) and the follow-up infant formula from 6 to 12 months of age | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diarrhea and all infections with fever | Mean event rate of diarrhea and all infections with fever per child over 6 months and 1 year | over 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Frequency of episodes of morbidity (adverse events), especially mean event rate of respiratory illnesses per child over 6 months and 1 year | over 6 months and 1 year | 
| Anthropometry | Anthropometry (weight (kg), length (cm), head circumference (cm) and skin fold) | until 1 year | 
| Digestive tolerance | Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic) | until 1 year | 
| Stool characteristics | Stool bacterial populations (Bifidobacteria, Lactobacilli Species, Clostridium, Bacteroides, Staphylococci epidermitis, presence or absence of B. lactis) Stool pH Stool and saliva S.IgA Stool Alpha 1-antitrypsine as infection/inflammation marker | at 3 and 6 months |