UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048633 |
|---|---|
| Receipt number | R000055416 |
| Scientific Title | Follow-up study of Bifidobacterium administration |
| Date of disclosure of the study information | 2022/08/10 |
| Last modified on | 2026/08/12 20:32:35 |
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Basic information
Public title
Follow-up study for infants enrolled in the Bifidobacterium effect study
Acronym
Follow-up study for infants enrolled in the Bifidobacterium effect study
Scientific Title
Follow-up study of Bifidobacterium administration
Scientific Title:Acronym
Follow-up study of Bifidobacterium administration
Region
| Japan |
Condition
Condition
Term infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Long-term follow-up for infants enrolled in the "Effect of Bifidobacterium bifidum administration on term infants at 1 year of age: An open-label randomized control trial" study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Growth and development and fecal microflora at 3 years of age
Key secondary outcomes
Parent-child relationship at 3 years of age
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Bifidobacterium administration during the first month of life.
Interventions/Control_2
Placebo
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 | days-old | <= |
Age-upper limit
| 3 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Term infants
Key exclusion criteria
Without consent
Severe co-morbidities
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Marie |
| Middle name | |
| Last name | Yoneyama |
Organization
Tokyo Health Care University
Division name
Health Care Science
Zip code
110
Address
4-1-17 Higashigotanda, Shinagawa, Tokyo
TEL
03-5421-7655
kusuda-satoshi@umin.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kusuda |
Organization
Neonatal Research Network of Japan
Division name
Neonatology
Zip code
110
Address
N30 Shinjuku Park Tower, 3-7-1 Nishishinjuku, Sinjuku, Tokyo
TEL
03-5326-3386
Homepage URL
kusuda-satoshi@nrnj.org
Sponsor or person
Institute
Tokyo Health Care University
Institute
Department
Personal name
Funding Source
Organization
Neonatal Research Network of Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Meiji Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Health Care University
Address
4-1-17 Higashigotanda, Shinagawa, Tokyo
Tel
03-5421-7655
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
東京医療保健大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.ryouken.or.jp/thema/c2/c2-2025.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ryouken.or.jp/thema/c2/c2-2025.html
Number of participants that the trial has enrolled
62
Results
Sixty-two infants were randomly assigned to the intervention (n = 32) or the control group (n = 30). Thirty-nine infants (19 and 10, respectively) completed follow-up through 3 years of age.
Results date posted
| 2026 | Year | 08 | Month | 12 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Under preparation of a manuscript.
Date of the first journal publication of results
| 2027 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
Sex (male/female), gestational age (weeks), birth weight (g), mode of delivery (vaginal/cesarean), and 1-minute Apgar score were 14/11 vs. 12/10, 38.8+/- 1.0 vs. 39.0+/-1.2, 3072+/- 346 vs. 3074+/-397, 27/5 vs. 24/6, and 9.0+/-0.2 vs. 9.0+/-0, respectively, in the intervention group (n = 32) and control group (n = 30), with no significant differences between the groups.
Participant flow
At randomization, there were 32 and 30 infants in the intervention and control groups, respectively. At 1, 2, and 3 years of age, 21 and 17, 20 and 11, and 19 and 10 infants, respectively, were followed up.
Adverse events
No advers event reported.
Outcome measures
Primary outcome: Defecation records through 1 year of age.
Secondary outcomes: Physical growth, incidences of allergic diseases, neurodevelopment outcomes, Child-Rearing Support Questionnaire, and gut microbiota at 1,2, and 3 years of age.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 09 | Day |
Last modified on
| 2026 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055416
