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Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis 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: NCT01531179
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Necrotizing Enterocolitis Very Low Birth Weight Infants Drug: Lactobacillus reuteri Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants
Study Start Date : February 2012
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Effect of Lactobacillus reuteri on culture proved sepsis [ Time Frame: up to 6 months ]
    Patients with culture positivity will accept as proven sepsis.

  2. Effect of Lactobacillus reuteri on weight gain [ Time Frame: up to 6 months ]
    The infants will be weight daily on scales that will calibrated weekly.

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


Eligibility Criteria

Information from the National Library of Medicine

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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

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): NCT01531179


Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: February 2013

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