Status:
COMPLETED
Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula
Lead Sponsor:
Beneo-Institute
Collaborating Sponsors:
Laboratorios Ordesa
European Union
Conditions:
Infection
Microbial Colonization
Eligibility:
All Genders
1-4 years
Phase:
NA
Brief Summary
The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-healt...
Detailed Description
The study primarily aimed to evaluate the effects of long-term supplementation of an infant formula with a mixture of short and long chain inulin-type oligosaccharides on immunological-health related ...
Eligibility Criteria
Inclusion
- Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for gestational age (between percentiles 3 and 97)
- Healthy babies aged between 0 - 4 months of age
- Babies exclusively fed with an infant formula on enrolment into the study
Exclusion
- The presence of an infection at the moment of the recruitment or 1 week before recruitment
- The presence of important pathologies (intestinal, cardiopathy, mental retardation, etc.)
- Any other diseases related to the immune system (primary immunodeficiency)
- Parents not able to comply with the study follow up (according to physician criteria)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2010
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04441359
Start Date
June 1 2008
End Date
October 31 2010
Last Update
June 22 2020
Active Locations (8)
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1
ZNA Koningin Paola Kinderziekenhuis
Antwerp, Belgium
2
Universitair Ziekenhuis
Brussels, Belgium
3
CAP Llefià
Barcelona, Spain
4
Hospital de Nens
Barcelona, Spain