FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-001324-31-IT
Enrollment
Unknown
Registered
2008-06-25
Start date
2008-07-09
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

necrotising enterocolitis (NEC MedDRA version: 9.1 Level: LLT Classification code 10014878 Term: Enteritis necroticans

Interventions

Product Name: Lactobacillus Reuterii DSM 17938 Pharmaceutical Form: Oral suspension Concentration unit: CFU/ml colony forming unit(s)/millilitre Concentration type: equal Concentration number: 2- Phar

Sponsors

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) birth weight =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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: 1. gut colonization by pathogenic bacteria 2. rate of nosocomial infections 3. security of oral supplementation with this probiotic in preterm infants (rate of sepsis caused by L. reuteri) 4. feeding tolerance (days needed to reach total enteral nutrition) 5. growth 6. rate of fat absorption in the gut 7. length of CVC stay (days) 8. length of total/partial parenteral nutrition (days) 9. length of the hospital stay (days) 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.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026