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

Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01531192
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
10
Duration (Months)
30
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lactobacillus reuteri

Lactobacillus reuteri 100 million CFU/day for 3 months

Dietary Supplement: Lactobacillus reuteri
Lactobacillus reuteri 100 million CFU/day for 3 months
Other Names:
  • BioGaia

    		•
    Active Comparator: Nystatin

    50000 unit/3 times a day

    Drug: Nystatin
    50000 unit/3 times a day, both for orally and by orogastric route
    Other Names:
  • Mikostatin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants [up to 6 months]

      Rectal and skin swabs for Candida colonization will be taken weekly. Blood culture for Candida infection will be taken weekly.

    Secondary Outcome Measures

    1. Effect of Lactobacillus reuteri on feeding intolerance [up to 6 months]

      Feeding intolerance (gastric residuals in the amount that was more than half of the previous feeding, abdominal distention or heme-positive stools)

    2. Effect of Lactobacillus reuteri on sepsis [up to 6 months]

      Patients with culture positivity will accept as proven sepsis.

    3. Effect of Lactobacillus reuteri on length of hospital stay [up to 6 months]

      Specified length of hospital stay as days.

    4. Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants [up to 6 months]

      NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 6 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology Ankara Turkey 06110

    Sponsors and Collaborators

    • Zekai Tahir Burak Women's Health Research and Education Hospital

    Investigators

    • Principal Investigator: Mehmet Yekta Oncel, MD, Neonatology

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Mehmet Yekta, Principal Investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
    ClinicalTrials.gov Identifier:
    NCT01531192
    Other Study ID Numbers:
    • ZTB630301
    First Posted:
    Feb 10, 2012
    Last Update Posted:
    Jul 16, 2013
    Last Verified:
    Feb 1, 2012
    Keywords provided by Mehmet Yekta, Principal Investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
    Lactobacillus reuteri
    Nystatin
    Very Low Birth Weight Infants
    Candida Colonization
    Additional relevant MeSH terms:
    Birth Weight
    Nystatin

    Study Results

    No Results Posted as of Jul 16, 2013