NCT01411761

Brief Summary

Indirect hyperbilirubinemia is frequently observed in premature infants.Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system. In this study we aimed to compare the effect of S. boulardii on severity of hyperbilirubinemia and duration of phototherapy on 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
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 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

May 1, 2011

Completed
3 months 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

June 1, 2011

Enrollment Period

7 months

First QC Date

August 5, 2011

Last Update Submit

August 5, 2011

Conditions

Indirect Hyperbilirubinemia

Keywords

indirect hyperbilirubinemiavery low birth weight infants

Outcome Measures

Primary Outcomes (1)

  • Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration

    6 months

Secondary Outcomes (1)

  • long term effect of S.boulardii on neurodevelopmental outcome

    6 months

Study Arms (2)

Saccharomyces boulardii

EXPERIMENTAL

study group

Dietary Supplement: Reflor

placebo

PLACEBO COMPARATOR

serum physiologic

Other: serum physiologic

Interventions

ReflorDIETARY_SUPPLEMENT

5 million unit/day, first 15 day of life

Saccharomyces boulardii
serum physiologicOTHER

1 cc added to one feeding in a day

placebo

Eligibility Criteria

Age1 Day - 15 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • very low birth weight infants

You may not qualify if:

  • chromosomal anomalies

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

Study Officials

  • Gamze Demirel, MD

    Zekai Tahir Burak Women's Health Research and Education Hospital

    PRINCIPAL INVESTIGATOR

  • Ugur Dilmen, Prof

    Zekai Tahir Burak Maternit Teaching Hospital

    STUDY DIRECTOR

Central Study Contacts

Gamze Demirel, MD

CONTACT

+905324540156kgamze@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 8, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 8, 2011

Record last verified: 2011-06

Locations

TU(1)