Effects of a Synbiotics-containing Starter Formula on Infant Growth
Study Details
Study Description
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 | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- mean weight gain [6 months]
Secondary Outcome Measures
- digestive tolerance [6 months]
Eligibility Criteria
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:
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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.)
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 09.02 INF