Prebiotics in the Prevention of Necrotizing Enterocolitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Necrotizing Enterocolitis

Intervention / Treatment
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* Dietary Supplement: Galacto-oligosaccharide (GOS)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prebiotics<br>Babies randomized to this arm will receive galacto-oligosaccharide supplements | Dietary Supplement: Galacto-oligosaccharide (GOS)<br>* Treatment group to receive 1.3 gm/kg/day GOS from initiation of enteral feeds until 35 weeks post-conceptual age.<br>|
| Placebo Comparator: Placebo<br>Babies randomized to this arm will receive placebo | Other: Placebo<br>* Similar quantity of sterile water to be added to milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Necrotizing Enterocolitis |  | yearly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fecal calprotectin, urine IFABP |  | end of study | 
| NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement] |  | yearly | 
| Stool bifidobacteria |  | End of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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galacto-oligosaccharides, prebiotics, NEC