Status:
COMPLETED
Evaluation of Safety, Tolerance and Effects on the Intestinal Flora of a New Fermented Milk for Preterm Infants
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Blédina SA, Villefranche sur Saône, France
Conditions:
Preterms With Gestational Age Ranging From 30 to 35 Weeks
Eligibility:
All Genders
1-15 years
Phase:
NA
Brief Summary
The intestinal flora is a complex ecosystem which is known to play various important functions in the gut. Recent data have reported a delay in intestinal colonization in preterm. Modulating the intes...
Detailed Description
This prospective, randomized, double-blind, controlled study evaluated the safety and effect on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm infants. Preterm i...
Eligibility Criteria
Inclusion
- Preterms with gestational age ranging from 30 to 35 weeks
- Eutrophic
- Formula feeding
Exclusion
- Malformation or metabolic disease
- Newborns whose parents did not provide informed consent
- Contraindication to enteral feeding
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00711633
Start Date
December 1 2002
End Date
June 1 2007
Last Update
July 9 2008
Active Locations (1)
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1
Neonatat unit, Saint Vincent de Paul Hospital
Paris, France, 75014