UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044070 |
|---|---|
| Receipt number | R000050317 |
| Scientific Title | Effect of Bifidobacterium bifidum on constipation |
| Date of disclosure of the study information | 2021/05/15 |
| Last modified on | 2025/08/29 19:46:15 |
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Basic information
Public title
Effect of Bifidobacterium bifidum on constipation in term infants during the 1st year of life
Acronym
Effect of Bifidobacterium bifidum on constipation during the 1st year of life
Scientific Title
Effect of Bifidobacterium bifidum on constipation
Scientific Title:Acronym
Bifidobacterium bifidum constipation trial
Region
| Japan |
Condition
Condition
Constipation in infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of Bifidobacterium on constipation during the 1st year of life
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Constipation during the 1st year of life
Key secondary outcomes
Morbidities during the 1st year of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
From day 5 to 1 month of age, term infants will receive Bifidobacterium bifidum.
Interventions/Control_2
Infants will receive the only dextrin.
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
| Not applicable |
Age-upper limit
| 6 | days-old | > |
Gender
Male and Female
Key inclusion criteria
Term newborn infants
Key exclusion criteria
1.Severe infection
2.Severe congenital anomalies
3.Other reasons determined by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kusuda |
Organization
Neonatal Research Network of Japan
Division name
Network
Zip code
160-1030
Address
3-7-1 Nishishinjuku
TEL
0353263386
kusuda-satoshi@nrnj.org
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kusuda |
Organization
Jiseikai Maternity Hospital
Division name
Obstetrics
Zip code
2520303
Address
6-19-26 Sagamiohno, Sagamihara, Kanagawa 2520303, Japan
TEL
042-742-3636
Homepage URL
kusuda-satoshi@nrnj.org
Sponsor or person
Institute
Neonatal Research Network of Japan
Institute
Department
Personal name
Funding Source
Organization
No funding souce
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Meiji Co.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jiseikai Maternity Hospital
Address
6-19-26 Sagamiohno, Minami, Sagamihara, Kanagawa 2520303, Japan
Tel
042-742-3636
kusuda-satoshi@nrnj.org
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
慈誠会マタニティーホスピタル
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
doi: 10.31488/bjg.1000127
Publication of results
Published
Result
URL related to results and publications
doi: 10.31488/bjg.1000127
Number of participants that the trial has enrolled
44
Results
21 in the Control and 23 in the Intervention Groups were enrolled. Growth and development at 1 year of age were not different between groups at 1 yera of age. However, in the secondary analysis, infants in the IG had significantly fewer days without defecation (9.9 vs. 16.3%, p < 0.01, chi-square test).
Early life probiotic supplementation in term infants may improve bowel movements during the first year of life.
Results date posted
| 2025 | Year | 08 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 20 | Day |
Baseline Characteristics
Gender ratio, gestational age, birth weight of the intervention and the control groups were 12/6, 5/12; 38.8, 39.0; 3028, 3004, respectively.
Participant flow
The newborns born at the hospital were divided into two groups. The Bifidobacterium group will receive a Bifidobacterium preparation daily until one month of age, while the control group will receive no special intervention. Growth and developmental outcomes at one year of age, along with daily defecation patterns during the first year, will then be compared between the two groups.
Adverse events
No
Outcome measures
Growth and development at 1 yerar of age and daily defecation status through 1 year of age.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 04 | Month | 28 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050317
