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Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns
This study has been completed.
Sponsored by: Nantes University Hospital
Information provided by: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00290576
  Purpose

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
Duration of Parenteral Nutrition
 Dietary Supplement: Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )

Drug Information available for: Sulfalene
U.S. FDA Resources
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

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition [ Time Frame: at D14 and D21. ]

Secondary Outcome Measures:
  • Age when Enteral Nutrition reaches 50% of Nutritional needs.
  • Incidence of Nosocomial Infections.
  • Composition of Colic Flora.
  • Fecal Calprotectin as Index of Inflammation

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)
  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. newborns (< 2 weeks of life)
  2. 32 Weeks of Gestation,
  3. weight < 1500g,
  4. Enteral nutrition begun,
  5. Clinical stability,
  6. Signed consent form from both parents.

Exclusion Criteria:

  1. newborns (>= 2 weeks of life),
  2. weight >= 1500g,
  3. pathology avoiding the start of the enteral nutrition,
  4. other pathologies of those due to premature and its complications,
  5. No signed consent form.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290576

Locations
France
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Dominique Darmaun, MD Nantes UH
  More Information

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

Keywords provided by Nantes University Hospital:
Digestive and Nutritional Effects
Safety and Growth
Feeding Tolerance

Study placed in the following topic categories:
Sulfalene

ClinicalTrials.gov processed this record on January 16, 2009



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