Effect of Saccharomyces Boulardii on Indirect Hyperbilirubinemia and Phototherapy Duration in Very Low Birth Weight Infants

NCT ID: NCT01411761

Last Updated: 2011-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Indirect Hyperbilirubinemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Saccharomyces boulardii

study group

Group Type EXPERIMENTAL

Reflor

Intervention Type DIETARY_SUPPLEMENT

5 million unit/day, first 15 day of life

placebo

serum physiologic

Group Type PLACEBO_COMPARATOR

serum physiologic

Intervention Type OTHER

1 cc added to one feeding in a day

Interventions

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Reflor

5 million unit/day, first 15 day of life

Intervention Type DIETARY_SUPPLEMENT

serum physiologic

1 cc added to one feeding in a day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* very low birth weight infants

Exclusion Criteria

* chromosomal anomalies
Minimum Eligible Age

1 Day

Maximum Eligible Age

15 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zekai Tahir Burak Maternity and Teaching Hospital

Principal Investigators

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Gamze Demirel, MD

Role: PRINCIPAL_INVESTIGATOR

Zekai Tahir Burak Women's Health Research and Education Hospital

Ugur Dilmen, Prof

Role: STUDY_DIRECTOR

Zekai Tahir Burak Maternit Teaching Hospital

Locations

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Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gamze Demirel, MD

Role: CONTACT

+905324540156

Facility Contacts

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Gamze Demirel, MD

Role: primary

+905324540156

Omer Erdeve, Assoc Prof

Role: backup

Other Identifiers

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demirel9800

Identifier Type: -

Identifier Source: org_study_id

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