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Sponsored by: |
Nantes University Hospital |
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Information provided by: | Nantes University Hospital |
ClinicalTrials.gov Identifier: | NCT00290576 |
Symbiotic interaction between probiotics ("Living alimentary microbials supplemental, affecting positively host by improving intestinal microbial equilibrium" (Fuller, 1989)) and human digestive tract was amply experimented and seems to be an interesting solution to orientate neonates digestive flora. Many studies showed a probant efficiency of probiotic supplementation in neonates on ECUN, despite abnormally high ECUN incidence in control group. Nevertheless, our aim is to test clinical efficiency of two new probiotics strains. Bifidobacterium Longum and Lactobacillus GG on Oral Nutrition (volume at Day 14 and Day 21) and safety (Adverse Events) in very premature babies.
Condition | Intervention |
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Duration of Parenteral Nutrition |
Dietary Supplement: Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG ) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns |
Enrollment: | 127 |
Study Start Date: | April 2004 |
Study Completion Date: | June 2008 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 2 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | BRD/04/2-Y |
Study First Received: | February 10, 2006 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00290576 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Digestive and Nutritional Effects Safety and Growth Feeding Tolerance |
Sulfalene |