Effects of a Synbiotics-containing Starter Formula on Infant Growth

April 20, 2012 updated by: Nestlé

Growth of Infants Consuming Starter Formula Containing Synbiotics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 2 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Test formula 1
Standard formula with prebiotics
Other: Standard infant formula with prebiotics
From 0-6 months of age. As per standard requirement
EXPERIMENTAL: test product
Infant formula with synbiotics
Other: Infant formula with synbiotics
From 0-6 months of age as per standard requirement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean weight gain
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
digestive tolerance
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Collaborators

National University Hospital, Singapore

Investigators

  • Principal Investigator: Dr. Lee Le Ye, MD, National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 6, 2009

First Posted (ESTIMATE)

November 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2012

Last Update Submitted That Met QC Criteria

April 20, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09.02 INF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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