Prebiotics in the Prevention of Necrotizing Enterocolitis

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00437567
Study type	Interventional
Source	Shaare Zedek Medical Center
Contact	Cathy Hammerman, MD
Phone	9722 666-6238
Email	cathy@cc.huji.ac.il
Status	Recruiting
Phase	Phase 2
Start date	July 2009
Completion date	July 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05544097` - Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis	N/A
Recruiting	`NCT03210831` - Early Predictors of Necrotizing Enterocolitis in Neonates
Not yet recruiting	`NCT06045130` - PUFAs in Preterm Infants
Recruiting	`NCT02552706` - The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis	N/A
Completed	`NCT02400697` - Placental Transfusion Project for Preterm Infants	N/A
Completed	`NCT01751477` - Infloran® for Prevention of Necrotizing Enterocolitis	N/A
Terminated	`NCT01156480` - Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants	N/A
Completed	`NCT00787124` - Transfusions and Nitric Oxide Level in Preterm Infants
Unknown status	`NCT00254176` - Cysteine Supplementation in Critically Ill Neonates	Phase 2/Phase 3
Recruiting	`NCT01441739` - Intestinal Failure in Necrotising Enterocolitis	N/A
Recruiting	`NCT03869827` - Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
Recruiting	`NCT04074824` - A Genome-Wide Association Study for Neonatal Diseases
Terminated	`NCT03320785` - Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Active, not recruiting	`NCT03554278` - Alteration of Stool Microbiota in Preterm Infants With Anemia
Not yet recruiting	`NCT04541771` - The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants	Phase 2
Not yet recruiting	`NCT03700957` - The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates	N/A
Completed	`NCT03551600` - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Unknown status	`NCT01807858` - The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants	N/A
Completed	`NCT01745510` - Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates	Phase 1/Phase 2
Completed	`NCT01735578` - Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis	N/A