Prebiotics in the Prevention of Necrotizing Enterocolitis
Prebiotics vs. Placebo in the Prevention of Necrotizing Enterocolitis in Premature Neonates
1 other identifier
interventional
260
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2007
CompletedFirst Posted
Study publicly available on registry
February 21, 2007
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJanuary 3, 2014
January 1, 2014
5 years
February 8, 2007
January 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Necrotizing Enterocolitis
yearly
Secondary Outcomes (3)
fecal calprotectin, urine IFABP
end of study
NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement]
yearly
Stool bifidobacteria
End of study
Study Arms (2)
Prebiotics
ACTIVE COMPARATORBabies randomized to this arm will receive galacto-oligosaccharide supplements
Placebo
PLACEBO COMPARATORBabies randomized to this arm will receive placebo
Interventions
Treatment group to receive 1.3 gm/kg/day GOS from initiation of enteral feeds until 35 weeks post-conceptual age.
Eligibility Criteria
You may qualify if:
- Preterm neonates
- \< 1750 gm birth weight
You may not qualify if:
- Infants who are deemed unlikely to survive
- Infants with significant congenital malformations
- Infants with other gastrointestinal problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Related 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. doi: 10.1016/j.jpeds.2005.03.054.
PMID: 16126048BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cathy Hammerman, MD
Shaare Zedek Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
February 8, 2007
First Posted
February 21, 2007
Study Start
July 1, 2009
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
January 3, 2014
Record last verified: 2014-01