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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WITHDRAWN
PHASE2
INTERVENTIONAL
2012-01-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Intervention Group I
Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture I
Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I
Intervention Group II
Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture II
Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture II
Control Group
Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides
Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides
Reference group
Exclusively breast-fed infants
No interventions assigned to this group
Interventions
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Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I
Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture II
Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides
Eligibility Criteria
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Inclusion Criteria
* Fully formula fed for at least one week (not applicable for the breastfeeding reference group since these infants must be exclusively breastfed before and throughout the study)
* Parents' or guardian's written informed consent
Exclusion Criteria
* Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
* Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps)
* Significant congenital abnormality that could affect the study results
* Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks preceding the study
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Gastroenteritis in the last two weeks before inclusion
8 Weeks
10 Weeks
ALL
Yes
Sponsors
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Danone Global Research & Innovation Center
INDUSTRY
Danone Asia Pacific Holdings Pte, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Sungkom Jongpiputvanich, A/Prof., MD.
Role: PRINCIPAL_INVESTIGATOR
Chulalongkorn University
Locations
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King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Phramongkutklao Hospital
Bangkok, , Thailand
Countries
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Other Identifiers
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COL.1.C/A
Identifier Type: -
Identifier Source: org_study_id