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Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns

Primary Purpose

Duration of Parenteral Nutrition

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Duration of Parenteral Nutrition focused on measuring Digestive and Nutritional Effects, Safety and Growth, Feeding Tolerance

Eligibility Criteria

1 Day - 2 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nantes University Hospital

Outcomes

Primary Outcome Measures

Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition

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

Full Information

First Posted
February 10, 2006
Last Updated
June 6, 2008
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00290576
Brief Title
Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns
Official Title
Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nantes University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duration of Parenteral Nutrition
Keywords
Digestive and Nutritional Effects, Safety and Growth, Feeding Tolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )
Primary Outcome Measure Information:
Title
Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition
Time Frame
at D14 and D21.
Secondary Outcome Measure Information:
Title
Age when Enteral Nutrition reaches 50% of Nutritional needs.
Title
Incidence of Nosocomial Infections.
Title
Composition of Colic Flora.
Title
Fecal Calprotectin as Index of Inflammation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Darmaun, MD
Organizational Affiliation
Nantes UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22152114
Citation
Bourdon A, Rouge C, Legrand A, Des Robert C, Piloquet H, Vodovar M, Voyer M, Roze JC, Darmaun D. Urinary citrulline in very low birth weight preterm infants receiving intravenous nutrition. Br J Nutr. 2012 Oct;108(7):1150-4. doi: 10.1017/S0007114511006660. Epub 2011 Dec 12.
Results Reference
derived
PubMed Identifier
19369375
Citation
Rouge C, Piloquet H, Butel MJ, Berger B, Rochat F, Ferraris L, Des Robert C, Legrand A, de la Cochetiere MF, N'Guyen JM, Vodovar M, Voyer M, Darmaun D, Roze JC. Oral supplementation with probiotics in very-low-birth-weight preterm infants: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2009 Jun;89(6):1828-35. doi: 10.3945/ajcn.2008.26919. Epub 2009 Apr 15.
Results Reference
derived

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Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns

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