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NCT Number: NCT01010113

Effects of a Synbiotics-containing Starter Formula on Infant Growth

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.

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Key information

Conditions

Infant Nutrition

Age range

11 day–17 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard infant formula with prebiotics

Other

From 0-6 months of age. As per standard requirement

Infant formula with synbiotics

Other

From 0-6 months of age as per standard requirement

Primary outcomes

  1. mean weight gain

    Time frame: 6 months

Secondary outcomes

  1. digestive tolerance

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • National University Hospital, Singapore

Registry information

Official study title

Growth of Infants Consuming Starter Formula Containing Synbiotics

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2009
Registry last updated
Apr 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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