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Effects of a Synbiotics-containing Starter Formula on Infant Growth

This study has been completed.
Sponsor:
Collaborator:
National University Hospital, Singapore
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01010113
First received: November 5, 2009
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Infant Nutrition
 Other: Standard infant formula with prebiotics
Other: Infant formula with synbiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Growth of Infants Consuming Starter Formula Containing Synbiotics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • mean weight gain [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • digestive tolerance [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Standard infant formula with prebiotics
Experimental: test product
Infant formula with synbiotics
 Other: Infant formula with synbiotics
From 0-6 months of age as per standard requirement
Other Name: Infant formula with synbiotics

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.

  Eligibility

Ages Eligible for Study:   up to 17 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010113

Locations
Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
Nestlé
National University Hospital, Singapore
Investigators
Principal Investigator: Dr. Lee Le Ye, MD National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01010113     History of Changes
Other Study ID Numbers: 09.02 INF
Study First Received: November 5, 2009
Last Updated: April 20, 2012
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Nestlé:
infants
prebiotics
probiotics
safety

ClinicalTrials.gov processed this record on May 19, 2013