Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns
Not Applicable
Completed
- Conditions
- Duration of Parenteral Nutrition
- Registration Number
- NCT00290576
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
Inclusion Criteria
- newborns (< 2 weeks of life)
- 32 Weeks of Gestation,
- weight < 1500g,
- Enteral nutrition begun,
- Clinical stability,
- Signed consent form from both parents.
Exclusion Criteria
- newborns (>= 2 weeks of life),
- weight >= 1500g,
- pathology avoiding the start of the enteral nutrition,
- other pathologies of those due to premature and its complications,
- No signed consent form.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition at D14 and D21.
- Secondary Outcome Measures
Name Time Method Age when Enteral Nutrition reaches 50% of Nutritional needs. Incidence of Nosocomial Infections. Composition of Colic Flora. Fecal Calprotectin as Index of Inflammation
Trial Locations
- Locations (1)
Nantes University Hospital
🇫🇷Nantes, France