Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies

Prevention of NEC in Preterm Infants With B. Lactis

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00977912

Enrollment

318

Registered

2009-09-16

Start date

2009-11-30

Completion date

2013-09-30

Last updated

2013-11-25

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

Conditions

Necrotizing Enterocolitis

Keywords

B. lactis, Preterm, Necrotizing Enterocolitis (NEC)

Brief summary

The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.

Interventions

DIETARY_SUPPLEMENTProbiotic supplementation

one capsule containing probiotics per day added to milk

DIETARY_SUPPLEMENTMilk containing placebo

one capsule containing placebo per day added to milk

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Hours to 48 Hours

Healthy volunteers

Yes

Inclusion criteria

* Weight between 800 - 1500g * Tolerating enteral feeding within 48 hours * Having obtained his/her parents or legal representative informed consent

Exclusion criteria

* Chromosomal abnormality * Hydrops featalis * Congenital malformation of the gastrointestinal tract * Congenital heart defects or other major congenital abnormalities likely to affect feeding and/or feeding tolerance * Currently participating in another clinical trial

Design outcomes

Primary

Measure	Time frame
NEC onset	6 weeks

Secondary

Measure	Time frame
Antibiotic administration and stool microbiology	6 weeks

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026