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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01531179

Enrollment

400

Registered

2012-02-10

Start date

2012-02-29

Completion date

2013-02-28

Last updated

2013-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Enterocolitis, Very Low Birth Weight Infants

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.

Interventions

DRUGLactobacillus reuteri

Lactobacillus reuteri 100 million CFU/day for 3 months

DRUGPlacebo

Placebo for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Days to 6 Months

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

Design outcomes

Primary

Measure	Time frame	Description
Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants	up to 6 months	NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.

Secondary

Measure	Time frame	Description
Effect of Lactobacillus reuteri on culture proved sepsis	up to 6 months	Patients with culture positivity will accept as proven sepsis.
Effect of Lactobacillus reuteri on weight gain	up to 6 months	The infants will be weight daily on scales that will calibrated weekly.
Effect of Lactobacillus reuteri on length of hospital stay	up to 6 months	Specified length of hospital stay as days

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026