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Prebiotics in the Prevention of Necrotizing Enterocolitis

NCT00437567 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2014-01-03

No results posted yet for this study

Summary

Necrotizing enterocolitis (NEC) is the most common gastrointestinal catastrophe affecting 10-15% of premature neonates of \<1500 gm. NEC is a disease of the immature intestine, characterized by impaired mucosal barrier function leading to increased gut permeability. We have previously demonstrated a protective effect of probiotic administration against the development of NEC. Others have shown that prebiotics can stimulate natural production of bifidobacteria and lactobacillus in the preterm gut. We have therefore hypothesized that prophylactic administration of prebiotics would also provide protection against necrotizing enterocolitis in the premature neonate, without the potential for sepsis which has been reported on rare occasions with probiotics administration.

Conditions

  • Necrotizing Enterocolitis

Interventions

DIETARY_SUPPLEMENT

Galacto-oligosaccharide (GOS)

Treatment group to receive 1.3 gm/kg/day GOS from initiation of enteral feeds until 35 weeks post-conceptual age.

OTHER

Placebo

Similar quantity of sterile water to be added to milk

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Principal Investigators

  • Cathy Hammerman, MD · Shaare Zedek Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00437567 on ClinicalTrials.gov