UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029087 |
|---|---|
| Receipt number | R000033271 |
| Scientific Title | Effect of Bifidobacterium bifidum supplementation on growth and development of term infants at 1 year of age |
| Date of disclosure of the study information | 2017/09/11 |
| Last modified on | 2022/08/09 15:19:14 |
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Basic information
Public title
Effect of Bifidobacterium bifidum supplementation on growth and development of term infants at 1 year of age
Acronym
Effect of Bifidobacterium on growth and development of term infants
Scientific Title
Effect of Bifidobacterium bifidum supplementation on growth and development of term infants at 1 year of age
Scientific Title:Acronym
Effect of Bifidobacterium on growth and development of term infants
Region
| Japan |
Condition
Condition
Term infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the efficacy of Bifidobacterium bifidum OLB6378 on morbidities during the first year
, and growth and development at 1 year of age among term infants
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Morbidities during the first year of life
Key secondary outcomes
Growth and development at 1 year of age
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Bifidobacterium bifidum OLB6378 powder (Meiji Co., Ltd., Tokyo, Japan) (0.5g/package) is administered twice a day, and continued until 1 month after birth
Interventions/Control_2
No administration
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
| 1 | months-old | <= |
Age-upper limit
| 12 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Term infants
Key exclusion criteria
Infants with complications
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kusuda |
Organization
NPO Neonatal Research Network
Division name
Headquaters
Zip code
110-0015
Address
Higashiueno
TEL
0338350435
skusuda@boshi.twmu.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kusuda |
Organization
kyorindai university
Division name
Headquaters
Zip code
110-0015
Address
Higashiueno
TEL
0338350435
Homepage URL
kusuda-satoshi@umin.ac.jp
Sponsor or person
Institute
NPO Neonatal Research Network
Institute
Department
Personal name
Funding Source
Organization
NPO Neonatal Research Network
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shiseikai Daini Hospital
Tokyo Women's Medical University Maternal and Perinatal Center
Meiji Milk Company
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiseikai 2nd Hospital IRB
Address
5-19-1 Kamisoshigaya, Setagaya, Tokyo
Tel
03-3300-3666
kusuda-satoshi@umin.ac.jp
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
至誠会第二病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
https://britishjournalofgastroenterology.com/
Publication of results
Published
Result
URL related to results and publications
https://britishjournalofgastroenterology.com/
Number of participants that the trial has enrolled
44
Results
In total, 44 infants were enrolled in this study, 21 in the Control (CG) and 23 in the Intervention (IG). Data of 17 infants in the CG and 18 in the IG were analyzed. Groth and developmental quotients at one year of age were not statistically different between the groups. However, infants in the IG had significantly fewer days without defecation.
Results date posted
| 2022 | Year | 08 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
21 in the Control Group and 23 in the Intervention Group.
Participant flow
Follow-up until 1 year old after the enrollment in the study,
Adverse events
None
Outcome measures
Growth, neurological development, and defecation status
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 11 | Day |
Last modified on
| 2022 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033271
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