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

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase: Completed; Phase 3

Conditions: Very Low Birth Weight Infants; Necrotizing Enterocolitis

Treatments: Drug: Lactobacillus reuteri; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01531179

ZTB6303

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 1 day to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

Lactobacillus reuteri

Experimental group

Description:

Lactobacillus reuteri 100 million CFU/day for 3 months

Treatment:

Drug: Lactobacillus reuteri

Control

Placebo Comparator group

Description:

Placebo for 3 months

Treatment:

Drug: Placebo