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Prebiotics in the Prevention of Necrotizing Enterocolitis

Prebiotics vs. Placebo in the Prevention of Necrotizing Enterocolitis in Premature Neonates

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00437567
Enrollment
260
Registered
2007-02-21
Start date
2009-07-31
Completion date
2014-07-31
Last updated
2014-01-03

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

Conditions

Necrotizing Enterocolitis

Keywords

galacto-oligosaccharides, prebiotics, NEC

Brief 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.

Detailed description

Specifically, we hope to demonstrate that fewer of the babies who are treated with galacto-oligosaccharides (GOS) will develop NEC as compared with controls. Preterm neonates, \<1750 gm birth weight will potentially be candidates for study. They will be randomly assigned to receive one of two milk additives from the time enteral feeds are begun until 35 weeks post-conceptual age: prebiotics (GOS) or placebo (water). All infants will be followed prospectively for signs of feeding intolerance and/or development of NEC. These will be compared between the two groups.

Interventions

DIETARY_SUPPLEMENTGalacto-oligosaccharide (GOS)

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

OTHERPlacebo

Similar quantity of sterile water to be added to milk

Sponsors

Shaare Zedek Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 7 Days
Healthy volunteers
No

Inclusion criteria

* Preterm neonates * \< 1750 gm birth weight

Exclusion criteria

* Infants who are deemed unlikely to survive * Infants with significant congenital malformations * Infants with other gastrointestinal problems

Design outcomes

Primary

MeasureTime frame
Incidence of Necrotizing Enterocolitisyearly

Secondary

MeasureTime frame
fecal calprotectin, urine IFABPend of study
NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement]yearly
Stool bifidobacteriaEnd of study

Countries

Israel

Contacts

Primary ContactCathy Hammerman, MD
cathy@cc.huji.ac.il9722 666-6238
Backup ContactAlona Bin-nun, MD
alona.binnun@gmail.com97250 868-5757

Outcome results

None listed

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