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Prebiotics in the Prevention of Necrotizing Enterocolitis

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ClinicalTrials.gov Identifier: NCT00437567
Recruitment Status : Unknown
Verified January 2014 by Cathy Hammerman, Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : February 21, 2007
Last Update Posted : January 3, 2014
Sponsor:
Information provided by (Responsible Party):
Cathy Hammerman, Shaare Zedek Medical Center

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prebiotics vs. Placebo in the Prevention of Necrotizing Enterocolitis in Premature Neonates
Study Start Date : July 2009
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Incidence of Necrotizing Enterocolitis [ Time Frame: yearly ]

Secondary Outcome Measures :
  1. fecal calprotectin, urine IFABP [ Time Frame: end of study ]
  2. NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement] [ Time Frame: yearly ]
  3. Stool bifidobacteria [ Time Frame: End of study ]


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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: January 2014

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

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