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Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns

NCT00290576 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2008-06-09

No results posted yet for this study

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.

Conditions

  • Duration of Parenteral Nutrition

Interventions

DIETARY_SUPPLEMENT

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

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Dominique Darmaun, MD · Nantes UH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2007-04-30
Completion
2008-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00290576 on ClinicalTrials.gov