NCT01315821

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 8, 2011

Status Verified

February 1, 2011

Enrollment Period

10 months

First QC Date

February 24, 2011

Last Update Submit

August 4, 2011

Conditions

Necrotizing EnterocolitisVery Low Birth Weight Infants

Keywords

Saccharomyces boulardiinecrotizing enterocolitis

Outcome Measures

Primary Outcomes (1)

  • Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants

    up to 6 months

Secondary Outcomes (4)

  • Effect of Saccharomyces boulardii on culture proved sepsis

    6 months

  • Effect of Saccharomyces boulardii on weight gain

    up to 6 months

  • Effect of Saccharomyces boulardii on length of hospital stay

    up to 6 months

  • Effect of Saccharomyces boulardii on mortality

    up to 6 months

Study Arms (2)

Saccharomyces boulardii

EXPERIMENTAL

Saccharomyces boulardii 5 million unit/day for 3 months

Drug: Saccharomyces boulardii

control

PLACEBO COMPARATOR

Placebo- for 3 months

Drug: Placebo

Interventions

Saccharomyces boulardiiDRUG

5 million units/day for 3 months

Also known as: Reflor
Saccharomyces boulardii
PlaceboDRUG

Placebo for 3 months

control

Eligibility Criteria

Age1 Day - 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Very low birth weight infants \< 1500 gr

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6.

    PMID: 37493095DERIVED

  • Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.

    PMID: 33058137DERIVED

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Gamze Demirel, MD

    Zekai Tahir Burak Women's Health Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gamze Demirel, MD

CONTACT

+903123065270kgamze@hotmail.com

Ugur Dilmen

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2011

First Posted

March 15, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 8, 2011

Record last verified: 2011-02

Locations

TU(1)