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Effects of a Synbiotics-containing Starter Formula on Infant Growth

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ClinicalTrials.gov Identifier: NCT01010113
Recruitment Status : Completed
First Posted : November 9, 2009
Last Update Posted : April 23, 2012
National University Hospital, Singapore
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Infant Nutrition Other: Standard infant formula with prebiotics Other: 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Growth of Infants Consuming Starter Formula Containing Synbiotics
Study Start Date : November 2009
Primary Completion Date : April 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. mean weight gain [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. digestive tolerance [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010113

National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Principal Investigator: Dr. Lee Le Ye, MD National University Hospital, Singapore

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01010113     History of Changes
Other Study ID Numbers: 09.02 INF
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: April 23, 2012
Last Verified: April 2012

Keywords provided by Nestlé: