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Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

Primary Purpose

Very Low Birth Weight Infants

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Lactobacillus reuteri
Nystatin
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 Very Low Birth Weight Infants focused on measuring Lactobacillus reuteri, Nystatin, Very Low Birth Weight Infants, Candida Colonization

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, Division of Neonatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lactobacillus reuteri

Nystatin

Arm Description

Lactobacillus reuteri 100 million CFU/day for 3 months

50000 unit/3 times a day

Outcomes

Primary Outcome Measures

Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants
Rectal and skin swabs for Candida colonization will be taken weekly. Blood culture for Candida infection will be taken weekly.

Secondary Outcome Measures

Effect of Lactobacillus reuteri on feeding intolerance
Feeding intolerance (gastric residuals in the amount that was more than half of the previous feeding, abdominal distention or heme-positive stools)
Effect of Lactobacillus reuteri on sepsis
Patients with culture positivity will accept as proven sepsis.
Effect of Lactobacillus reuteri on length of hospital stay
Specified length of hospital stay as days.
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.

Full Information

First Posted
February 4, 2012
Last Updated
July 13, 2013
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01531192
Brief Title
Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
Official Title
Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey
Study Type
Interventional

2. Study Status

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

5. Study Description

Brief Summary
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic Lactobacillus reuteri in reducing the candida colonization and infection 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
Very Low Birth Weight Infants
Keywords
Lactobacillus reuteri, Nystatin, Very Low Birth Weight Infants, Candida Colonization

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (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
Nystatin
Arm Type
Active Comparator
Arm Description
50000 unit/3 times a day
Intervention Type
Dietary Supplement
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)
Nystatin
Other Intervention Name(s)
Mikostatin
Intervention Description
50000 unit/3 times a day, both for orally and by orogastric route
Primary Outcome Measure Information:
Title
Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants
Description
Rectal and skin swabs for Candida colonization will be taken weekly. Blood culture for Candida infection will be taken weekly.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Effect of Lactobacillus reuteri on feeding intolerance
Description
Feeding intolerance (gastric residuals in the amount that was more than half of the previous feeding, abdominal distention or heme-positive stools)
Time Frame
up to 6 months
Title
Effect of Lactobacillus reuteri on sepsis
Description
Patients with culture positivity will accept as proven sepsis.
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
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

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, Division of Neonatology
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
25245226
Citation
Oncel MY, Arayici S, Sari FN, Simsek GK, Yurttutan S, Erdeve O, Saygan S, Uras N, Oguz SS, Dilmen U. Comparison of Lactobacillus reuteri and nystatin prophylaxis on Candida colonization and infection in very low birth weight infants. J Matern Fetal Neonatal Med. 2015;28(15):1790-4. doi: 10.3109/14767058.2014.968842. Epub 2014 Oct 9.
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
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0001400619&QV1=NYSTATIN
Description
Nystatin

Learn more about this trial

Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

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