Prebiotics in the Prevention of Necrotizing Enterocolitis

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00437567
• Other study ID #: SZMC/CH/32007
• Status: Recruiting
• Phase: Phase 2
• First received: February 8, 2007
• Last updated: January 2, 2014
• Start date: July 2009
• Est. completion date: July 2014

Study information

• Verified date: January 2014
• Source: Shaare Zedek Medical Center
• Contact: Cathy Hammerman, MD
• Phone: 9722 666-6238
• Email: cathy[@]cc.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

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

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Dietary Supplement:
• Galacto-oligosaccharide (GOS)
Treatment group to receive 1.3 gm/kg/day GOS from initiation of enteral feeds until 35 weeks post-conceptual age.

Other:
• Placebo
Similar quantity of sterile water to be added to milk

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Bin-Nun A, Bromiker R, Wilschanski M, Kaplan M, Rudensky B, Caplan M, Hammerman C. Oral probiotics prevent necrotizing enterocolitis in very low birth weight neonates. J Pediatr. 2005 Aug;147(2):192-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Necrotizing Enterocolitis		yearly	No
Secondary	fecal calprotectin, urine IFABP		end of study	No
Secondary	NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement]		yearly	Yes
Secondary	Stool bifidobacteria		End of study	No