- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01315821
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
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
- Name: Gamze Demirel, MD
- Phone Number: +903123065270
- Email: kgamze@hotmail.com
Study Contact Backup
- Name: Ugur Dilmen
Study Locations
-
-
-
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
|
5 million units/day for 3 months
Other Names:
|
PLACEBO_COMPARATOR: control
Placebo- for 3 months
|
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.
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.
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
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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