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Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis 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:
NCT01531179
First received: February 4, 2012
Last updated: May 8, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Necrotizing Enterocolitis
Very Low Birth Weight Infants
 Drug: Lactobacillus reuteri
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Further study details as provided by Zekai Tahir Burak Maternity and Teaching Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Effect of Lactobacillus reuteri on culture proved sepsis [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Patients with culture positivity will accept as proven sepsis.

  • Effect of Lactobacillus reuteri on weight gain [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    The infants will be weight daily on scales that will calibrated weekly.

  • Effect of Lactobacillus reuteri on length of hospital stay [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Specified length of hospital stay as days


Enrollment: 400
Study Start Date: February 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactobacillus reuteri
Lactobacillus reuteri 100 million CFU/day for 3 months
 Drug: Lactobacillus reuteri
Lactobacillus reuteri 100 million CFU/day for 3 months
Other Name: BioGaia
Placebo Comparator: Control
Placebo for 3 months
 Drug: Placebo
Placebo for 3 months
Other Name: Placebo

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531179

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit
Ankara, Turkey, 06110
Sponsors and Collaborators
Zekai Tahir Burak Maternity and Teaching Hospital
Investigators
Principal Investigator: Mehmet Yekta Oncel, MD Neonatology
  More Information

Additional Information:
Lactobacillus reuteri  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Mehmet Yekta, Principal Investigator, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01531179     History of Changes
Other Study ID Numbers: ZTB6303
Study First Received: February 4, 2012
Last Updated: May 8, 2013
Health Authority: Turkey: Ethics Committee

Additional relevant MeSH terms:
Birth Weight
Enterocolitis
Enterocolitis, Necrotizing
Body Weight
Signs and Symptoms
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 21, 2013