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Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns

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ClinicalTrials.gov Identifier: NCT00290576
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : June 9, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Duration of Parenteral Nutrition Dietary Supplement: Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG ) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns
Study Start Date : April 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

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


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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290576


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

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
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: June 9, 2008
Last Verified: June 2008

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sulfalene
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents