Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns

Duration of Parenteral Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290576
• Other study ID #: BRD/04/2-Y
• Status: Completed
• Phase: N/A
• First received: February 10, 2006
• Last updated: June 6, 2008
• Start date: April 2004
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: June 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Weeks

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Duration of Parenteral Nutrition
• Premature Birth

Intervention

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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition		at D14 and D21.
Secondary	Age when Enteral Nutrition reaches 50% of Nutritional needs.
Secondary	Incidence of Nosocomial Infections.
Secondary	Composition of Colic Flora.
Secondary	Fecal Calprotectin as Index of Inflammation