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

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

Sponsors

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

Source Zekai Tahir Burak Women's Health Research and Education Hospital
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.

Overall Status Completed
Start Date February 2012
Completion Date February 2013
Primary Completion Date February 2013
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants up to 6 months
Secondary Outcome
Measure Time Frame
Effect of Lactobacillus reuteri on culture proved sepsis up to 6 months
Effect of Lactobacillus reuteri on weight gain up to 6 months
Effect of Lactobacillus reuteri on length of hospital stay up to 6 months
Enrollment 400
Condition
Intervention

Intervention Type: Drug

Intervention Name: Lactobacillus reuteri

Description: Lactobacillus reuteri 100 million CFU/day for 3 months

Arm Group Label: Lactobacillus reuteri

Other Name: BioGaia

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo for 3 months

Arm Group Label: Control

Eligibility

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

Gender: All

Minimum Age: N/A

Maximum Age: 6 Months

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mehmet Yekta Oncel, MD Principal Investigator Neonatology
Location
Facility: Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit
Location Countries

Turkey

Verification Date

February 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital

Investigator Full Name: Mehmet Yekta

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Lactobacillus reuteri

Type: Experimental

Description: Lactobacillus reuteri 100 million CFU/day for 3 months

Label: Control

Type: Placebo Comparator

Description: Placebo for 3 months

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov