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Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.

NCT02073214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2014-02-27

No results posted yet for this study

Summary

The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates. The study was also intended to investigate reduction of colonisation by pathogenic bacteria and to estimate the incidence of gastrointestinal disorders.

Probotic bacteria contained in the investigational product administered directly after birth are beneficial for the development of normal gut microflora and can prevent or significantly limit gastrointestinal colonisation by pathogenic bacteria and the development of pathogenic flora in a hospital setting. Permanent colonisation with commensal flora in very early life improves gastrointestinal function in premature neonates by reducing the onset of or by decreasing the severity of the signs and symptoms of feeding intolerance and generalised bacterial infections, including sepsis and necrotizing enterocolitis.

Conditions

  • Late Onset Neonatal Sepsis
  • Necrotizing Enterocolitis
  • Infant, Very Low Birth Weight

Interventions

OTHER

Probiotic

Standard treatment plus probiotic

OTHER

Placebo

Standard treatment plus placebo

Sponsors & Collaborators

  • Ministry of Science and Higher Education, Poland

    collaborator OTHER_GOV

  • IBSS Biomed S.A.

    lead INDUSTRY

Principal Investigators

  • Ryszard Lauterbach, Prof., MD · Jagiellonian University Medical College, Department of Neonatology, Kopernika 23 St., 31-501 Krakow, Poland

  • Aleksandra M Cichonska, PhD · IBSS Biomed S.A.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-07-31
Completion
2013-12-31

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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 NCT02073214 on ClinicalTrials.gov