Effects of a Synbiotics-containing Starter Formula on Infant Growth

Nestlé

Status

Completed

Conditions

Infant Nutrition

Treatments

Other: Infant formula with synbiotics

Other: Standard infant formula with prebiotics

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01010113

09.02 INF

Details and patient eligibility

About

In this study the investigators want to evaluate the satiety of two infant formulas, one containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy measurement for the healthy development of an infant, will be assessed in both groups and compared to the growth observed in the WHO Child Growth Standards in order to demonstrate non inferiority.

Full description

Growth studies continue to be a centrepiece of clinical evaluation of infant formulas. In order to standardize growth, the investigator proposes to calculate the weight-for-age Z-score related to the WHO Child Growth Standards. Z-scores express the difference between the measurement of an individual and the median value of the reference population as a proportion of the SD of the reference population taking into account age and gender.

The hypothesis to be tested is that infants fed with starter formula with prebiotics and probiotics blend and those fed only with probiotics will grow as much as infants in the reference growth of WHO.

Other parameters such as digestive tolerance, frequency of morbidity and microbiota pattern will also be investigated.

Enrollment

140 patients

Sex

All

Ages

11 to 17 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy newborn infant
Age at point of enrolment ≤14 days
Birthweight ≥2500g and ≤4500g
Full term infant ≥37 weeks gestation and ≤42 weeks gestation
Singleton births
Having obtained his/her or his/her legal representative's informed consent

Exclusion criteria

Congenital illness or malformation that may affect normal growth
Significant pre-natal or post-natal disease
Re-hospitalisation for more than 2 days during the first 14 days of life (Exceptionally, infants hospitalized because of jaundice may be enrolled in the study.)
Receiving infant formula containing probiotics and/or prebiotics prior to enrollment and/or at the time of enrollment
Patient who cannot be expected to comply with treatment
Currently participating or having participated in another clinical trial prior to the beginning of this study