Status:
WITHDRAWN
Colonisation Resistance Study
Lead Sponsor:
Danone Asia Pacific Holdings Pte, Ltd.
Collaborating Sponsors:
Danone Global Research & Innovation Center
Conditions:
Healthy Infants
Eligibility:
All Genders
8-10 years
Phase:
PHASE2
Brief Summary
This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.
Eligibility Criteria
Inclusion
- Healthy term infants (gestational age 37 to 42 weeks) aged 2-2.5 months at inclusion
- 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
- Being weaned before inclusion (introduction of any other foods other than formula or breast milk.)
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01507935
Start Date
January 1 2012
End Date
November 1 2012
Last Update
September 5 2012
Active Locations (2)
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1
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
2
Phramongkutklao Hospital
Bangkok, Thailand