Prebiotics in the Prevention of Necrotizing Enterocolitis

January 2, 2014 updated by: Cathy Hammerman, Shaare Zedek Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

260

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91031
        • Recruiting
        • Shaare Zedek Medical Center
        • Principal Investigator:
          • Cathy Hammerman, MD
        • Sub-Investigator:
          • Alona Bin-nun, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Necrotizing Enterocolitis
Time Frame: yearly
yearly

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

February 8, 2007

First Submitted That Met QC Criteria

February 19, 2007

First Posted (Estimate)

February 21, 2007

Study Record Updates

Last Update Posted (Estimate)

January 3, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZMC/CH/32007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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