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| Name | Class |
|---|---|
| National University Hospital, Singapore | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test formula 1 | Placebo Comparator | Standard formula with prebiotics |
|
| test product | Experimental | Infant formula with synbiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard infant formula with prebiotics | Other | From 0-6 months of age. As per standard requirement |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean weight gain | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| digestive tolerance | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Lee Le Ye, MD | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27057326 | Derived | Lee le Y, Bharani R, Biswas A, Lee J, Tran LA, Pecquet S, Steenhout P. Normal growth of infants receiving an infant formula containing Lactobacillus reuteri, galacto-oligosaccharides, and fructo-oligosaccharide: a randomized controlled trial. Matern Health Neonatol Perinatol. 2015 Apr 7;1:9. doi: 10.1186/s40748-015-0008-3. eCollection 2015. |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D041943 | Infant Formula |
| D058616 | Synbiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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| Infant formula with synbiotics | Other | From 0-6 months of age as per standard requirement |
|
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D005526 | Food, Formulated |
| D019648 | Foods, Specialized |
| D007225 | Infant Food |
| D019936 | Probiotics |