Nutritional Safety
Conditions
Keywords
Formula, Feeding, Healthy, Full, Term, Infants
Brief summary
The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with a prebiotic component (GOS) in improving the gut microflora balance, mimicking that of breast-fed infants.
Detailed description
Oligosaccharides are one of the major breast milk components. They are not digested and reach the colon where they're used by selected groups of microflora positive bacteria, specifically bifidobacteria and lactobacilli. Therefore, oligosaccharides have prebiotic effects accountable for health benefits in infants. Over the last years the supplementation of infant formulae has been studied to mimic breast milk prebiotic functions enhancing gut microflora growth similar to that of breast fed infants. However further scientific data are necessary to support the efficacy of the supplementation of oligosaccharide in infant formulae.
Interventions
OTHERInfant formula (with GOS)
Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides
Sponsors
Heinz Italia SpA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 15 Days
Healthy volunteers
No
Inclusion criteria
1. Healthy infants of both sexes, born at term with natural labor or cesarean birth 2. Single birth 3. Infant born between 37th - 42th gestation week (included) 4. Infant with birth weight ≥ 2500 g 5. APGAR score after 5 minutes of life \> 7 6. Infant born from parents of Caucasian race 7. Exclusive breast feeding or formula feeding within 15 days from birth. 8. Consensus form signed by both parents or by the legal tutor properly informed of the study. 9. Parents able to understand the protocol requirements and to fill out the infants Diary.
Exclusion criteria
1. Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days. 2. Diseases jeopardizing intrauterine growth. 3. Infant born from mother suffering from dismetabolic and/or chronic diseases. 4. Unknown father 5. Infant with parents who might not report at hospital controls or not follow the protocol. 6. Infant already enrolled or selected for another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The nutritional safety through anthropometric controls. Adverse events: diarrhea, crying, gaseous colics, regurgitation, vomit, skin rashes, fever. | Anthropometric controls at birth, on enrolment, after 1, 2, 3, 4 months of life and just before starting weaning. Adverse events daily. |
Secondary
| Measure | Time frame |
|---|---|
| The prebiotic effect through the control of the feces consistency and frequency, the incidence of gaseous colics and microbiological analyses of the fecal samples. | Feces consistency and frequency, and incidence of gaseous colics, microbiological analyses of the fecal samples on enrolment and after 1 and 2 months of life. |
Countries
Italy
Outcome results
None listed