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Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics

NCT02226263 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-08-27

No results posted yet for this study

Summary

The purpose of this study is to know the effects of probiotics on the incidence of Necrotizing Enterocolitis (NEC) in preterm infants less than 1500 g.

Conditions

Interventions

DIETARY_SUPPLEMENT

probiotics Lactobacillus acidophilus boucardii

Using sterile technique, the probiotic with 1x109 \[CFU\] Lactobacillus acidophilus boucardii strain was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks to fresh supplement breast milk or formula for preterm infants.

Sponsors & Collaborators

  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • Guadalupe Gómez, M.D. · Universidad de Guanajuato

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
27 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

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 NCT02226263 on ClinicalTrials.gov