search
Back to results

Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants

Primary Purpose

Necrotizing Enterocolitis, Very Low Birth Weight Infants

Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Lactobacillus reuteri
Placebo
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Necrotizing Enterocolitis

Eligibility Criteria

1 Day - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Very low birth weight infants < 1500 gr
  • Gestational age < 32 weeks

Exclusion Criteria:

  • Genetic anomalies
  • Short bowel syndrome
  • Not willing to participate
  • Allergy to Lactobacillus reuteri components

Sites / Locations

  • Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactobacillus reuteri

Control

Arm Description

Lactobacillus reuteri 100 million CFU/day for 3 months

Placebo for 3 months

Outcomes

Primary Outcome Measures

Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants
NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.

Secondary Outcome Measures

Effect of Lactobacillus reuteri on culture proved sepsis
Patients with culture positivity will accept as proven sepsis.
Effect of Lactobacillus reuteri on weight gain
The infants will be weight daily on scales that will calibrated weekly.
Effect of Lactobacillus reuteri on length of hospital stay
Specified length of hospital stay as days

Full Information

First Posted
February 4, 2012
Last Updated
May 8, 2013
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01531179
Brief Title
Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants
Official Title
Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 g. Although bifidobacterium and other lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing enterocolitis in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence and severity of necrotizing enterocolitis in very low birth weight infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis, Very Low Birth Weight Infants

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus reuteri
Arm Type
Experimental
Arm Description
Lactobacillus reuteri 100 million CFU/day for 3 months
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo for 3 months
Intervention Type
Drug
Intervention Name(s)
Lactobacillus reuteri
Other Intervention Name(s)
BioGaia
Intervention Description
Lactobacillus reuteri 100 million CFU/day for 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 3 months
Primary Outcome Measure Information:
Title
Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants
Description
NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Effect of Lactobacillus reuteri on culture proved sepsis
Description
Patients with culture positivity will accept as proven sepsis.
Time Frame
up to 6 months
Title
Effect of Lactobacillus reuteri on weight gain
Description
The infants will be weight daily on scales that will calibrated weekly.
Time Frame
up to 6 months
Title
Effect of Lactobacillus reuteri on length of hospital stay
Description
Specified length of hospital stay as days
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Very low birth weight infants < 1500 gr Gestational age < 32 weeks Exclusion Criteria: Genetic anomalies Short bowel syndrome Not willing to participate Allergy to Lactobacillus reuteri components
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Yekta Oncel, MD
Organizational Affiliation
Neonatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
24309022
Citation
Oncel MY, Sari FN, Arayici S, Guzoglu N, Erdeve O, Uras N, Oguz SS, Dilmen U. Lactobacillus Reuteri for the prevention of necrotising enterocolitis in very low birthweight infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F110-5. doi: 10.1136/archdischild-2013-304745. Epub 2013 Dec 5.
Results Reference
derived
Links:
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=L040030000&QV1=LACTOBACILLUS+REUTERI
Description
Lactobacillus reuteri

Learn more about this trial

Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants

We'll reach out to this number within 24 hrs