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

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01315821
• Other study ID #: 1234
• Status: Recruiting
• Phase: Phase 3
• First received: February 24, 2011
• Last updated: August 4, 2011
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2011
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: Gamze Demirel, MD
• Phone: +903123065270
• Email: kgamze[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Months

Eligibility

Inclusion Criteria:

• Very low birth weight infants < 1500 gr

Exclusion Criteria:

• Genetic anomalies

• Not willing to participate

• Allergy to S. boulardii components

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis
• Very Low Birth Weight Infants

Intervention

Drug:
• Saccharomyces boulardii
5 million units/day for 3 months
• Placebo
Placebo for 3 months

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants		up to 6 months	No
Secondary	Effect of Saccharomyces boulardii on culture proved sepsis		6 months	No
Secondary	Effect of Saccharomyces boulardii on weight gain		up to 6 months	No
Secondary	Effect of Saccharomyces boulardii on length of hospital stay		up to 6 months	No
Secondary	Effect of Saccharomyces boulardii on mortality		up to 6 months	No