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

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ClinicalTrials.gov Identifier: NCT01315821
Recruitment Status : Unknown
Verified February 2011 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was:  Recruiting
First Posted : March 15, 2011
Last Update Posted : August 8, 2011
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Necrotizing Enterocolitis Very Low Birth Weight Infants Drug: Saccharomyces boulardii Drug: Placebo Phase 3

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  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Role Of Saccharomyces Boulardii in Preventin Necrotizing Enterocolitis in Very Low Birth Weight Infants
Study Start Date : February 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


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 Name: Reflor

Placebo Comparator: control
Placebo- for 3 months
Drug: Placebo
Placebo for 3 months




Primary Outcome Measures :
  1. Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Effect of Saccharomyces boulardii on culture proved sepsis [ Time Frame: 6 months ]
  2. Effect of Saccharomyces boulardii on weight gain [ Time Frame: up to 6 months ]
  3. Effect of Saccharomyces boulardii on length of hospital stay [ Time Frame: up to 6 months ]
  4. Effect of Saccharomyces boulardii on mortality [ Time Frame: up to 6 months ]


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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Zekai Tahir Burak Maternity Teaching Hospital
ClinicalTrials.gov Identifier: NCT01315821     History of Changes
Other Study ID Numbers: 1234
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: February 2011

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

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