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Prebiotics in the Prevention of Necrotizing Enterocolitis

This study is currently recruiting participants.
Verified April 2009 by Shaare Zedek Medical Center
Sponsor:
Information provided by (Responsible Party):
Cathy Hammerman, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00437567
First received: February 8, 2007
Last updated: December 9, 2012
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Necrotizing Enterocolitis
 Dietary Supplement: Galacto-oligosaccharide (GOS)
Other: Placebo
 Phase 2

Study Type: Interventional
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
Official Title: Prebiotics vs. Placebo in the Prevention of Necrotizing Enterocolitis in Premature Neonates

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Incidence of Necrotizing Enterocolitis [ Time Frame: yearly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fecal calprotectin, urine IFABP [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement] [ Time Frame: yearly ] [ Designated as safety issue: Yes ]
  • Stool bifidobacteria [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: July 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prebiotics
Babies randomized to this arm will receive galacto-oligosaccharide supplements
 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.
Placebo Comparator: Placebo
Babies randomized to this arm will receive placebo
 Other: Placebo
Similar quantity of sterile water to be added to milk

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.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437567

Contacts
Contact: Cathy Hammerman, MD 9722 666-6238 cathy@cc.huji.ac.il
Contact: Alona Bin-nun, MD 97250 868-5757 alona.binnun@gmail.com

Locations
Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Principal Investigator: Cathy Hammerman, MD            
Sub-Investigator: Alona Bin-nun, MD            
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Center
  More Information

Publications:

Responsible Party: Cathy Hammerman, Professor of Pediatrics, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00437567     History of Changes
Other Study ID Numbers: SZMC/CH/32007
Study First Received: February 8, 2007
Last Updated: December 9, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
galacto-oligosaccharides
prebiotics
NEC

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on June 17, 2013