Prebiotics in the Prevention of Necrotizing Enterocolitis

Shaare Zedek Medical Center

Status and phase: Unknown; Phase 2

Conditions: Necrotizing Enterocolitis

Treatments: Other: Placebo; Dietary Supplement: Galacto-oligosaccharide (GOS)

Study type: Interventional

Funder types: Other

Identifiers

NCT00437567

SZMC/CH/32007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: Under 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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260 participants in 2 patient groups, including a placebo group

Prebiotics

Active Comparator group

Description:

Babies randomized to this arm will receive galacto-oligosaccharide supplements

Treatment:

Dietary Supplement: Galacto-oligosaccharide (GOS)

Placebo

Placebo Comparator group

Description:

Babies randomized to this arm will receive placebo

Treatment:

Other: Placebo