Efficacy and security of oral supplementation with a probiotic (Lactobacillus reuteri) in newborns with birth weight < 1500 g: effects on necrotising enterocolitis (NEC) and gut colonization with gram negative bacteria. - NEO 2008-01

• Conditions: necrotising enterocolitis (NEC; MedDRA version: 9.1Level: LLTClassification code 10014878Term: Enteritis necroticans

• Registration Number: EUCTR2008-001324-31-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1)birth weight < 1500 gr (VLBW infants)
2)infants from 1 to 4 days-old
3)written informed consent signed by each infant?s parents
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

EXCLUSION CRITERIA :
1)anatomic gastrointestinal malformations
2)major congenital malformations
3)severe clinical conditions that, according to the researcher judgement, do not indicate the inclusion in the study
4)patients unable to follow the study protocol and to sign written informed consent. The consent must be signed also by parents/guardian or by the legal representative, if patients are underage or unable to give their consent. Underage patients and patients unable to give consent must sign the consent in so far as they can.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the effects of oral supplementation with a probiotic (Lactobacillus reuteri) on the reduction of the incidence rate of NEC stage &#61619; II in VLBW infants.;Secondary Objective: : to evaluate the efficacy and security of this probiotic, by the subsequent data:<br>1.gut colonization by pathogenic bacteria<br>2.rate of nosocomial infections<br>3.security of oral supplementation with this probiotic in preterm infants (rate of sepsis caused by L. reuteri)<br>4.feeding tolerance (days needed to reach total enteral nutrition) <br>5.growth <br>6.rate of fat absorption in the gut<br>7.length of CVC stay (days)<br>8.length of total/partial parenteral nutrition (days)<br>9.length of the hospital stay (days)<br>10.death (all causes);Primary end point(s): to evaluate the effects of oral supplementation with a probiotic (Lactobacillus reuteri) on the reduction of the incidence rate of NEC stage &#61619; II in VLBW infants.