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Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns

NCT ID: NCT00290576

Last Updated: 2008-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Duration of Parenteral Nutrition

Keywords

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Digestive and Nutritional Effects Safety and Growth Feeding Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Dominique Darmaun, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes UH

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 22152114 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19369375 (View on PubMed)

Other Identifiers

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BRD/04/2-Y

Identifier Type: -

Identifier Source: org_study_id