NCT01411748

Brief Summary

Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic S boulardii in reducing the candida colonization and infection 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
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_4

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

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
4 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

July 1, 2011

Enrollment Period

5 months

First QC Date

August 5, 2011

Last Update Submit

August 5, 2011

Conditions

Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants

Outcome Measures

Primary Outcomes (1)

  • Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants

    6 months

Secondary Outcomes (1)

  • Effect of S. boulardii on sepsis

    6 months

Study Arms (2)

S. boulardii

EXPERIMENTAL

The patients in this group will be given 5 million unit/day S. boulardii until discharge.

Dietary Supplement: Reflor

nystatin

ACTIVE COMPARATOR
Drug: mikostatin

Interventions

ReflorDIETARY_SUPPLEMENT

5 million unit/day, orally, beginning on the second day of life, until discharge from hospital

S. boulardii
mikostatinDRUG

50000 unit/3 times a day, both for orally and by orogastric route

nystatin

Eligibility Criteria

Age1 Day - 90 Days
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, Division of Neonatology

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Chapman RL. Prevention and treatment of Candida infections in neonates. Semin Perinatol. 2007 Feb;31(1):39-46. doi: 10.1053/j.semperi.2007.01.006.

    PMID: 17317426BACKGROUND

  • Murzyn A, Krasowska A, Stefanowicz P, Dziadkowiec D, Lukaszewicz M. Capric acid secreted by S. boulardii inhibits C. albicans filamentous growth, adhesion and biofilm formation. PLoS One. 2010 Aug 10;5(8):e12050. doi: 10.1371/journal.pone.0012050.

    PMID: 20706577BACKGROUND

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 8, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 8, 2011

Record last verified: 2011-07

Locations

TU(1)