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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01531192
First received: February 4, 2012
Last updated: July 13, 2013
Last verified: February 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

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

  • Effect of Lactobacillus reuteri on length of hospital stay [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
    Specified length of hospital stay as days.

  • Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.


Enrollment: 300
Study Start Date: June 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531192

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

Additional Information:
No publications provided

Responsible Party: Mehmet Yekta, Principal Investigator, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01531192     History of Changes
Other Study ID Numbers: ZTB630301
Study First Received: February 4, 2012
Last Updated: July 13, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by 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
Body Weight
Signs and Symptoms
Nystatin
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014