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Bifidobacterium Supplementation for Very Low Birth Weight Infants

NCT01375309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2012-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Preterm Infants

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium bifidum supplementation

Bifidobacterium bifidum supplementation wiht approximately 2.5\*10to9th bacteria per day

DIETARY_SUPPLEMENT

Placebo contains dextrin

0.5 of dextrin

Sponsors & Collaborators

  • Tokyo Women's Medical University

    lead OTHER

Principal Investigators

  • Satoshi Kusuda, MD · Tokyo Women's Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-06-30
Completion
2011-12-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01375309 on ClinicalTrials.gov