Effect of Starter Formula on Infection Prevention

Nestlé

Status: Completed

Conditions: Gastro-intestinal Infections; Infections With Fever

Treatments: Other: Placebo comparator; Other: starter infant formula with pro and prebiotics

Study type: Interventional

Funder types: Industry

Identifiers

NCT01880970

07.20.INF

Details and patient eligibility

About

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

Enrollment: 477 patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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477 participants in 3 patient groups, including a placebo group

Starter infant formula with pro and prebiotics

Active Comparator group

Description:

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

Treatment:

Other: starter infant formula with pro and prebiotics

starter infant formula without pro and prebiotics

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo comparator

Breastfeeding group

No Intervention group

Description:

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