Effects of a Synbiotics-containing Starter Formula on Infant Growth
NCT ID: NCT01010113
Last Updated: 2012-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2009-11-30
2011-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test formula 1
Standard formula with prebiotics
Standard infant formula with prebiotics
From 0-6 months of age. As per standard requirement
test product
Infant formula with synbiotics
Infant formula with synbiotics
From 0-6 months of age as per standard requirement
Interventions
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Standard infant formula with prebiotics
From 0-6 months of age. As per standard requirement
Infant formula with synbiotics
From 0-6 months of age as per standard requirement
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
11 Days
17 Days
ALL
Yes
Sponsors
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National University Hospital, Singapore
OTHER
Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Lee Le Ye, MD
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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National University Hospital
Singapore, , Singapore
Countries
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References
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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.
Other Identifiers
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09.02 INF
Identifier Type: -
Identifier Source: org_study_id
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