Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00290576
First received: February 10, 2006
Last updated: June 6, 2008
Last verified: June 2008
  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 )

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns

Resource links provided by NLM:


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
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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

No publications provided by Nantes University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00290576     History of Changes
Other Study ID Numbers: BRD/04/2-Y
Study First Received: February 10, 2006
Last Updated: June 6, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on October 23, 2014