- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00290576
Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns
June 6, 2008 updated by: Nantes University Hospital
Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
127
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nantes, France, 44093
- Nantes University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 2 weeks (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition
Time Frame: at D14 and D21.
|
at D14 and D21.
|
Secondary Outcome Measures
Outcome Measure |
---|
Age when Enteral Nutrition reaches 50% of Nutritional needs.
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Incidence of Nosocomial Infections.
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Composition of Colic Flora.
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Fecal Calprotectin as Index of Inflammation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dominique Darmaun, MD, Nantes UH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
February 10, 2006
First Submitted That Met QC Criteria
February 10, 2006
First Posted (Estimate)
February 13, 2006
Study Record Updates
Last Update Posted (Estimate)
June 9, 2008
Last Update Submitted That Met QC Criteria
June 6, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRD/04/2-Y
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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