Randomized, Double Blind Study to Evaluate the Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS) in Healthy, Full Term Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Heinz Italia SpA
- Enrollment
- 360
- Locations
- 7
- Primary Endpoint
- The nutritional safety through anthropometric controls. Adverse events: diarrhea, crying, gaseous colics, regurgitation, vomit, skin rashes, fever.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 15 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Healthy infants of both sexes, born at term with natural labor or cesarean birth
- •Single birth
- •Infant born between 37th - 42th gestation week (included)
- •Infant with birth weight ≥ 2500 g
- •APGAR score after 5 minutes of life > 7
- •Infant born from parents of Caucasian race
- •Exclusive breast feeding or formula feeding within 15 days from birth.
- •Consensus form signed by both parents or by the legal tutor properly informed of the study.
- •Parents able to understand the protocol requirements and to fill out the infants Diary.
Exclusion Criteria
- •Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days.
- •Diseases jeopardizing intrauterine growth.
- •Infant born from mother suffering from dismetabolic and/or chronic diseases.
- •Unknown father
- •Infant with parents who might not report at hospital controls or not follow the protocol.
- •Infant already enrolled or selected for another clinical trial.
Arms & Interventions
group "S"
Breast milk
group "A"
Control Infant formula
group "B"
Infant formula supplemented with 0.4 g/100 ml of oligosaccharides
Intervention: Infant formula (with GOS) (Other)
Outcomes
Primary Outcomes
The nutritional safety through anthropometric controls. Adverse events: diarrhea, crying, gaseous colics, regurgitation, vomit, skin rashes, fever.
Time Frame: Anthropometric controls at birth, on enrolment, after 1, 2, 3, 4 months of life and just before starting weaning. Adverse events daily.
Secondary Outcomes
- 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.)