Gastro-intestinal Infections, Infections With Fever
Conditions
Brief summary
The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.
Interventions
OTHERstarter infant formula with pro and prebiotics
OTHERPlacebo comparator
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diarrhea and all infections with fever | over 6 months and 1 year | Mean event rate of diarrhea and all infections with fever per child over 6 months and 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | over 6 months and 1 year | Frequency of episodes of morbidity (adverse events), especially mean event rate of respiratory illnesses per child over 6 months and 1 year |
| Anthropometry | until 1 year | Anthropometry (weight (kg), length (cm), head circumference (cm) and skin fold) |
| Digestive tolerance | until 1 year | Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic) |
| Stool characteristics | at 3 and 6 months | * 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 |
Countries
France, Germany, Netherlands
Outcome results
None listed