UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015742 |
|---|---|
| Receipt number | R000018317 |
| Scientific Title | Safety and Effect of Bifidobacterium breve M-16V Supplementation to sick infants. |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2017/05/26 16:26:42 |
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Basic information
Public title
Safety and Effect of Bifidobacterium breve M-16V Supplementation to sick infants.
Acronym
Safety and Effect of Bifidobacterium breve M-16V.
Scientific Title
Safety and Effect of Bifidobacterium breve M-16V Supplementation to sick infants.
Scientific Title:Acronym
Safety and Effect of Bifidobacterium breve M-16V.
Region
| Asia(except Japan) |
Condition
Condition
sick infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make sure the safety that there is no occurrence of adverse events and to prove its effectiveness during administration of bifidobacterium breve M-16V to sick infants in neonatal care unit of NMCHC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A significant increase is not observed in the incidence of adverse events in the two groups of comparison administration group and non-administration group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The NCU doctors instruct to administer Bifidobacteria breve (M-16V) to the
registered infants.
Interventions/Control_2
Control(non-adiministration) group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 0 | days-old | <= |
Age-upper limit
| 28 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
All the sick infants who are hospitalized in NCU amongthe newborn infants born in NMCHC.
Key exclusion criteria
the infants who already have caused gastrointestinal bleeding etc. and are considered to be unsuitable for administration of bifidobacterium into the stomach
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Hosokawa |
Organization
National Center for Global Health and Medicine
Division name
Pediatrics
Zip code
Address
Toyama 1-21-1, Shinjuku, Tokyo, Japan
TEL
03-3202-7181
shosokaw@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Hosokawa |
Organization
National Center for Global Health and Medicine
Division name
Pediatrics
Zip code
Address
Toyama 1-21-1, Shinjuku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
shosokaw@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Maternal and Child Health Centre
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 23 | Day |
Last modified on
| 2017 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018317
