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

August 5, 2011 updated by: Zekai Tahir Burak Women's Health Research and Education Hospital

Phase 4 Study of Saccharomyces Boulardii on Indirect Hyperbilirubinemia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06230
        • Recruiting
        • Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
        • Contact:
        • Contact:
          • Omer Erdeve, Assoc Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • very low birth weight infants

Exclusion Criteria:

  • chromosomal anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Saccharomyces boulardii
study group
Dietary supplement: Reflor
5 million unit/day, first 15 day of life
PLACEBO_COMPARATOR: placebo
serum physiologic
Other: serum physiologic
1 cc added to one feeding in a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
long term effect of S.boulardii on neurodevelopmental outcome
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Investigators

  • Study Director: Ugur Dilmen, Prof, Zekai Tahir Burak Maternit Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (ESTIMATE)

August 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 8, 2011

Last Update Submitted That Met QC Criteria

August 5, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • demirel9800

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Indirect Hyperbilirubinemia

Clinical Trials on Reflor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe