Bifidobacterium Supplementation for Very Low Birth Weight Infants (Bifido(RCT))

March 28, 2012 updated by: Satoshi Kusuda, Tokyo Women's Medical University

Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants

Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

246

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 Locations

  • Japan
    • Tokyo
      • Shinjuku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical Unversity

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 2 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants with birth weight less than 1500g

Exclusion Criteria:

  • Sever bacteremia
  • Congenital anomaly
  • Not suitable for the trial defined by an attending neonatologist

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active
Bifidobacterium bifidum
Dietary supplement: Bifidobacterium bifidum supplementation
Bifidobacterium bifidum supplementation wiht approximately 2.5*10to9th bacteria per day
Other Names:
  • Bifidobacterium bifidum OLB6378
Placebo Comparator: Placebo
Dextrin without Bifidobacterium bifidum
Dietary supplement: Placebo contains dextrin
0.5 of dextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postnatal day when enteral feeding exceeded at 100ml/kg/day
Time Frame: From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth
Death or unsuccessful of establishing enteral feeding exceeded at 100ml/kg/day before day 28 of age is considered failure to reach primary endpoint.
From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
standard deviation(SD) scores of bodyweight(BW) and head circumference(HC)
Time Frame: For the duration of NICU stay, an expected average of 3 months
BW gain/day, SD scores of BW and HC at discharge from NICU
For the duration of NICU stay, an expected average of 3 months
Necrotizing enterocolitis or sepsis
Time Frame: For the duration of NICU stay, an expected average of 3 months
The incidences of necrtizing enterocolitis or sepsis during the stay in NICU
For the duration of NICU stay, an expected average of 3 months
Intestinal flora
Time Frame: For the duration of NICU stay, an expected average of 3 months
Intestinal flora during the stay in NICU
For the duration of NICU stay, an expected average of 3 months

Collaborators and Investigators

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

Sponsor

Tokyo Women's Medical University

Investigators

  • Principal Investigator: Satoshi Kusuda, MD, Tokyo Women's Medical University

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

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

January 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 16, 2011

First Posted (Estimate)

June 17, 2011

Study Record Updates

Last Update Posted (Estimate)

March 30, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1675
  • UMIN000002543 (Other Identifier: University hospital Medical Information Network)

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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