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Probiotics Reduce Incidence of Necrotizing Enterocolitis for Very Low Birth Weight Infants

NCT00540033 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2007-10-05

No results posted yet for this study

Summary

We investigate the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis (NEC) for very low birth weight (VLBW) infants.A prospective, masked, multi-center randomized control trial will be conducted level III neonatal center to evaluate the beneficial effects of probiotics for NEC among VLBW (\<1500 g) infants. VLBW infants who start to feed enterally are eligible and are randomized into 2 groups after parental informed consents were obtained. Infants in the study group are fed with Infloran (Lactobacillus acidophilus and Bifidobacterium bifidus) with breast or formula milk twice daily for 6 weeks. Infants in the control group are fed with breast or formula milk alone. The clinicians caring for the infants are blinded to the group assignment. The primary outcome measurement is death or NEC (≧stage 2).

Conditions

  • Enterocolitis, Necrotizing

Interventions

DIETARY_SUPPLEMENT

infloran

Study group was fed with probiotics as infloran 125mg/kg/dose twice daily by adding it to breast milk or mixed feeding (breast and formula) for 6 weeks;

DIETARY_SUPPLEMENT

infloran

Study group was fed with infloran \[Lactobacilli acidophilus (CFU 109 NCDO 1748, obtained from the National Collection of Dairy Organisms)\] and Bifidobacteria bifidum \[(CFU 109, NCDO 1453 obtained from the National Collection of Dairy Organisms)\]; Laboratorio Farmaceutico S.I.T S.r.I ITALY\] 125mg/kg/dose twice daily by adding it to breast milk or mixed feeding (breast and formula) for 6 weeks;

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • HUNG-CHIH LIN, MD · Department of Pediatrics, Children Hospital, China Medical University, Taichung, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Completion
2007-06-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00540033 on ClinicalTrials.gov