Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants

Necrotizing Enterocolitis Clinical Trial

Official title:

Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531179
• Other study ID #: ZTB6303
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2012
• Last updated: May 8, 2013
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis
• Very Low Birth Weight Infants

Intervention

Drug:
• Lactobacillus reuteri
Lactobacillus reuteri 100 million CFU/day for 3 months
• Placebo
Placebo for 3 months

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants	NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.	up to 6 months	No
Secondary	Effect of Lactobacillus reuteri on culture proved sepsis	Patients with culture positivity will accept as proven sepsis.	up to 6 months	No
Secondary	Effect of Lactobacillus reuteri on weight gain	The infants will be weight daily on scales that will calibrated weekly.	up to 6 months	No
Secondary	Effect of Lactobacillus reuteri on length of hospital stay	Specified length of hospital stay as days	up to 6 months	No

External Links

•   Lactobacillus reuteri