Effects of a Synbiotics-containing Starter Formula on Infant Growth

Not Applicable

Completed

• Conditions: Infant Nutrition
• Interventions: Other: Standard infant formula with prebiotics; Other: Infant formula with synbiotics

• Registration Number: NCT01010113
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-06
• Study First Posted: 2009-11-09
• Primary Completion: 2011-04
• Study Completion: 2011-06
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-20
• Last Update Posted: 2012-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test formula 1	Standard infant formula with prebiotics	Standard formula with prebiotics
test product	Infant formula with synbiotics	Infant formula with synbiotics

Primary Outcome Measures

Name	Time	Method
mean weight gain	6 months

Secondary Outcome Measures

Name	Time	Method
digestive tolerance	6 months

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore