Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier:
NCT01315821
First received: February 24, 2011
Last updated: August 4, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Necrotizing Enterocolitis
Very Low Birth Weight Infants
Drug: Saccharomyces boulardii
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Role Of Saccharomyces Boulardii in Preventin Necrotizing Enterocolitis in Very Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of Saccharomyces boulardii on culture proved sepsis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Effect of Saccharomyces boulardii on weight gain [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Effect of Saccharomyces boulardii on length of hospital stay [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Effect of Saccharomyces boulardii on mortality [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: February 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saccharomyces boulardii
Saccharomyces boulardii 5 million unit/day for 3 months
Drug: Saccharomyces boulardii
5 million units/day for 3 months
Other Name: Reflor
Placebo Comparator: control
Placebo- for 3 months
Drug: Placebo
Placebo for 3 months
Other Name: placebo

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.

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Very low birth weight infants < 1500 gr

Exclusion Criteria:

  • Genetic anomalies
  • Not willing to participate
  • Allergy to S. boulardii components
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315821

Contacts
Contact: Gamze Demirel, MD +903123065270 kgamze@hotmail.com
Contact: Ugur Dilmen

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital Recruiting
Ankara, Turkey, 06230
Contact: Gamze Demirel         
Principal Investigator: Gamze Demirel, MD         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
Principal Investigator: Gamze Demirel, MD Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

No publications provided

Responsible Party: Zekai Tahir Burak Maternity Teaching Hospital
ClinicalTrials.gov Identifier: NCT01315821     History of Changes
Other Study ID Numbers: 1234
Study First Received: February 24, 2011
Last Updated: August 4, 2011
Health Authority: Turkey: Ethics Committee

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
Saccharomyces boulardii
necrotizing enterocolitis

Additional relevant MeSH terms:
Birth Weight
Body Weight
Enterocolitis
Enterocolitis, Necrotizing
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014