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
|Condition or disease||Intervention/treatment||Phase|
|Infant Nutrition||Other: Standard infant formula with prebiotics Other: Infant formula with synbiotics||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Growth of Infants Consuming Starter Formula Containing Synbiotics|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||June 2011|
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
- mean weight gain [ Time Frame: 6 months ]
- digestive tolerance [ Time Frame: 6 months ]
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|
|Principal Investigator:||Dr. Lee Le Ye, MD||National University Hospital, Singapore|