The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

March 7, 2013 updated by: Dilek Dilli, Dr. Sami Ulus Children's Hospital
Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants began eating until you are discharged from the hospital once a day to feed a group+ 900 mg of 5 billion active Bifidobacterium lactis, the addition of chicory inulin, in the other group given placebo; Patients taking weekly blood cultures, the presence of residues in both groups during feeding, to evaluate the incidence of NEC and sepsis are planned. Randomization and the number of patients planned to separate into groups.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients separated into four groups using the sealed envelope method.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

  • Name: Dilek Dilli, Assoc Prof
  • Phone Number: 00903123055000

Study Locations

  • Turkey
      • Bursa, Turkey
        • Recruiting
        • Şevket Yılmaz Research Hospital
        • Contact:
          • Arzu Akdağ, MD
        • Sub-Investigator:
          • Arzu Akdağ, MD
      • Diyarbakır, Turkey
        • Recruiting
        • Diyarbakır Research Hospital
        • Contact:
          • Banu Mutlu, MD
        • Sub-Investigator:
          • M. Şah Oğuz, MD
      • İstanbul, Turkey
        • Recruiting
        • Okmeydani Research Hospital
        • Contact:
          • Özden Turan, MD
        • Contact:
          • Özden Turan
        • Sub-Investigator:
          • Özden Turan, MD
      • İstanbul, Turkey
        • Recruiting
        • Umraniye Research Hospital
        • Contact:
          • Şenol Bozdağ, MD
        • Sub-Investigator:
          • Şenol Bozdağ

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

No older than 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • VLBW infants admitted to NICU at the first 7 days of life

Exclusion Criteria:

  • expected life lower than 7 days,
  • babies who could not be fed (any metabolic disorders, gastrointestinal system surgical disorders etc.),
  • severe asphyxia,
  • severe congenital anomaly

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Maltodextrin
Dietary supplement: Bifidobacterium lactis plus İnülin
5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given
Other Names:
  • 5 billion Bifidobacterium lactis plus 900 mg İnülin
Dietary supplement: İnulin
900 mg inulin per day will be given
Dietary supplement: Bifidobacterium lactis
5 billion active Bifidobacterium lactis
Active Comparator: Bifidobacterium lactis
5 billion Bifidobacterium lactis
Dietary supplement: Bifidobacterium lactis plus İnülin
5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given
Other Names:
  • 5 billion Bifidobacterium lactis plus 900 mg İnülin
Other: Maltodextrin
Maltodextrin
Dietary supplement: İnulin
900 mg inulin per day will be given
Active Comparator: İnulin
900 mg İnulin per day will be given
Dietary supplement: Bifidobacterium lactis plus İnülin
5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given
Other Names:
  • 5 billion Bifidobacterium lactis plus 900 mg İnülin
Other: Maltodextrin
Maltodextrin
Dietary supplement: Bifidobacterium lactis
5 billion active Bifidobacterium lactis
Active Comparator: Bifidobacterium lactis plus İnülin
5 billion active Bifidobacterium lactis plus 900 mg İnülin per day
Other: Maltodextrin
Maltodextrin
Dietary supplement: İnulin
900 mg inulin per day will be given
Dietary supplement: Bifidobacterium lactis
5 billion active Bifidobacterium lactis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Necrotizing enterocolitis
Time Frame: 8 weeks
Developing of >= grade 2 necrotizing enterocolitis suggested by radiological investigation
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospital stay
Time Frame: 16 weeks
length of hospital stay
16 weeks

Collaborators and Investigators

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

Sponsor

Dr. Sami Ulus Children's Hospital

Investigators

  • Principal Investigator: Dilek Dilli, MD, Assoc Prof

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

October 1, 2012

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

December 24, 2012

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimate)

March 8, 2013

Study Record Updates

Last Update Posted (Estimate)

March 8, 2013

Last Update Submitted That Met QC Criteria

March 7, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68/16.Oct.2012

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.

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