Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants

August 4, 2011 updated by: Zekai Tahir Burak Women's Health Research and Education Hospital

Role Of Saccharomyces Boulardii in Preventin Necrotizing Enterocolitis in Very Low Birth Weight Infants

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 gr. Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces boulardii has not been used in the prevention of NEC in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The primary outcome of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ugur Dilmen

Study Locations

  • Turkey
      • Ankara, Turkey, 06230
        • Recruiting
        • Zekai Tahir Burak Maternity Teaching Hospital
        • Contact:
          • Gamze Demirel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Very low birth weight infants < 1500 gr

Exclusion Criteria:

  • Genetic anomalies
  • Not willing to participate
  • Allergy to S. boulardii components

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Saccharomyces boulardii
Saccharomyces boulardii 5 million unit/day for 3 months
Drug: Saccharomyces boulardii
5 million units/day for 3 months
Other Names:
  • Reflor
PLACEBO_COMPARATOR: control
Placebo- for 3 months
Drug: Placebo
Placebo for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of Saccharomyces boulardii on culture proved sepsis
Time Frame: 6 months
6 months
Effect of Saccharomyces boulardii on weight gain
Time Frame: up to 6 months
up to 6 months
Effect of Saccharomyces boulardii on length of hospital stay
Time Frame: up to 6 months
up to 6 months
Effect of Saccharomyces boulardii on mortality
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (ESTIMATE)

March 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 8, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1234 (Department of Defense)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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