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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01531192
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : July 16, 2013
Sponsor:
Information provided by (Responsible Party):
Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital

Study Description
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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
Very Low Birth Weight Infants Dietary Supplement: Lactobacillus reuteri Drug: Nystatin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : June 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

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Arms and Interventions
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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 Name: 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 Name: Mikostatin


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to 6 months ]
    Patients with culture positivity will accept as proven sepsis.

  3. Effect of Lactobacillus reuteri on length of hospital stay [ Time Frame: up to 6 months ]
    Specified length of hospital stay as days.

  4. Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants [ Time Frame: up to 6 months ]
    NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.


Eligibility Criteria
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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT01531192


Locations
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Turkey
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
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Principal Investigator: Mehmet Yekta Oncel, MD Neonatology
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: February 10, 2012    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: February 2012
Keywords provided by Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital:
Lactobacillus reuteri
Nystatin
Very Low Birth Weight Infants
Candida Colonization
Additional relevant MeSH terms:
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Birth Weight
Body Weight
Nystatin
Anti-Bacterial Agents
Anti-Infective Agents
 Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action