Prebiotics in the Prevention of Necrotizing Enterocolitis

Phase 2

• Conditions: Necrotizing Enterocolitis
• Interventions: Dietary Supplement: Galacto-oligosaccharide (GOS); Other: Placebo

• Registration Number: NCT00437567
• Lead Sponsor: Shaare Zedek Medical Center

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.

Study Timeline

• Study First Submitted: 2007-02-08
• Study First Submitted QC: 2007-02-19
• Study First Posted: 2007-02-21
• Study Start: 2009-07
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-02
• Last Update Posted: 2014-01-03
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prebiotics	Galacto-oligosaccharide (GOS)	Babies randomized to this arm will receive galacto-oligosaccharide supplements
Placebo	Placebo	Babies randomized to this arm will receive placebo

Primary Outcome Measures

Name	Time	Method
Incidence of Necrotizing Enterocolitis	yearly

Secondary Outcome Measures

Name	Time	Method
fecal calprotectin, urine IFABP	end of study
NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement]	yearly
Stool bifidobacteria	End of study

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel