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OpenTrials
Completed

NCT Number: NCT00290576

Digestive and Nutritional Effects of Probiotics 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.

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Key information

Conditions

Duration of Parenteral Nutrition

Age range

1 day–2 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Dietary Supplement

Primary outcomes

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

    Time frame: at D14 and D21.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Feb 13, 2006
Registry last updated
Jun 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.