Prebiotics in the Prevention of Necrotizing Enterocolitis
Primary Purpose
Necrotizing Enterocolitis
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Galacto-oligosaccharide (GOS)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Necrotizing Enterocolitis focused on measuring galacto-oligosaccharides, prebiotics, NEC
Eligibility 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
Sites / Locations
- Shaare Zedek Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Prebiotics
Placebo
Arm Description
Babies randomized to this arm will receive galacto-oligosaccharide supplements
Babies randomized to this arm will receive placebo
Outcomes
Primary Outcome Measures
Incidence of Necrotizing Enterocolitis
Secondary Outcome Measures
fecal calprotectin, urine IFABP
NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement]
Stool bifidobacteria
Full Information
NCT ID
NCT00437567
First Posted
February 8, 2007
Last Updated
January 2, 2014
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00437567
Brief Title
Prebiotics in the Prevention of Necrotizing Enterocolitis
Official Title
Prebiotics vs. Placebo in the Prevention of Necrotizing Enterocolitis in Premature Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis
Keywords
galacto-oligosaccharides, prebiotics, NEC
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prebiotics
Arm Type
Active Comparator
Arm Description
Babies randomized to this arm will receive galacto-oligosaccharide supplements
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Babies randomized to this arm will receive placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Galacto-oligosaccharide (GOS)
Intervention Description
Treatment group to receive 1.3 gm/kg/day GOS from initiation of enteral feeds until 35 weeks post-conceptual age.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Similar quantity of sterile water to be added to milk
Primary Outcome Measure Information:
Title
Incidence of Necrotizing Enterocolitis
Time Frame
yearly
Secondary Outcome Measure Information:
Title
fecal calprotectin, urine IFABP
Time Frame
end of study
Title
NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement]
Time Frame
yearly
Title
Stool bifidobacteria
Time Frame
End of study
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathy Hammerman, MD
Phone
9722 666-6238
Email
cathy@cc.huji.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Alona Bin-nun, MD
Phone
97250 868-5757
Email
alona.binnun@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy Hammerman, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathy Hammerman, MD
First Name & Middle Initial & Last Name & Degree
Alona Bin-nun, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
16126048
Citation
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.
Results Reference
background
Learn more about this trial
Prebiotics in the Prevention of Necrotizing Enterocolitis
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