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Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns

N

Nantes University Hospital (NUH)

Status

Completed

Conditions

Duration of Parenteral Nutrition

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00290576
BRD/04/2-Y

Details and patient eligibility

About

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.

Enrollment

127 patients

Sex

All

Ages

1 day to 2 weeks old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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