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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044070
Receipt No. R000050317
Scientific Title Effect of Bifidobacterium bifidum on constipation
Date of disclosure of the study information 2021/05/15
Last modified on 2021/04/28

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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
Email 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
Email kusuda-satoshi@nrnj.org

Sponsor
Institute Neonatal Research Network of Japan
Institute
Department

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
Email 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
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 Preinitiation
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
2021 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050317

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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