Bifidobacterium Supplementation for Very Low Birth Weight Infants
NCT ID: NCT01375309
Last Updated: 2012-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
246 participants
INTERVENTIONAL
2010-01-31
2011-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active
Bifidobacterium bifidum
Bifidobacterium bifidum supplementation
Bifidobacterium bifidum supplementation wiht approximately 2.5\*10to9th bacteria per day
Placebo
Dextrin without Bifidobacterium bifidum
Placebo contains dextrin
0.5 of dextrin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bifidobacterium bifidum supplementation
Bifidobacterium bifidum supplementation wiht approximately 2.5\*10to9th bacteria per day
Placebo contains dextrin
0.5 of dextrin
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Congenital anomaly
* Not suitable for the trial defined by an attending neonatologist
48 Hours
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tokyo Women's Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Satoshi Kusuda
Professor of Neonatology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Satoshi Kusuda, MD
Role: PRINCIPAL_INVESTIGATOR
Tokyo Women's Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tokyo Women's Medical Unversity
Shinjuku, Tokyo, Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6.
Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UMIN000002543
Identifier Type: OTHER
Identifier Source: secondary_id
1675
Identifier Type: -
Identifier Source: org_study_id