Effect of Starter Formula on Infection Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

477 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-10-31

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.

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Detailed Description

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Conditions

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Gastro-intestinal Infections Infections With Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Starter infant formula with pro and prebiotics

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

Group Type ACTIVE_COMPARATOR

starter infant formula with pro and prebiotics

Intervention Type OTHER

starter infant formula without pro and prebiotics

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

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type OTHER

Breastfeeding group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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starter infant formula with pro and prebiotics

Intervention Type OTHER

Placebo comparator

Intervention Type OTHER

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

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes