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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046155
Receipt No. R000052684
Scientific Title Investigation of culture condition of enteric microbiota using laboratory culture device from stool
Date of disclosure of the study information 2021/11/24
Last modified on 2021/11/24

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Basic information
Public title Investigation of culture condition of enteric microbiota using laboratory culture device from stool
Acronym Investigation of culture condition of enteric microbiota using laboratory culture device from stool
Scientific Title Investigation of culture condition of enteric microbiota using laboratory culture device from stool
Scientific Title:Acronym Investigation of culture condition of enteric microbiota using laboratory culture device from stool
Region
Japan

Condition
Condition None
Classification by specialty
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of culture condition of enteric microbiota
Basic objectives2 Others
Basic objectives -Others Changes in intestinal microflora and components before and after incubation in a culture system
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in intestinal microflora and components before and after incubation in a culture system
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
6 months-old <=
Age-upper limit
12 months-old >=
Gender Male and Female
Key inclusion criteria Selection criteria for provisional registration
1.Infants who are between 6 and 12 months of age at the time of stool collection
2.Infants whose mothers aged 20 years or older, who understand Japanese and are judged to have sufficient capacity to make decisions regarding the conduct of this study, are the guardians of the infants and whose consent to participate in the study has been obtained as the consensus of the persons with parental authority

Selection criteria for definitive registration
1.Infants who could collect more than 10 g of stool for intestinal bacteria culture
Key exclusion criteria Exclusion criteria for provisional registration
1.Children of mothers who did not agree to submit a written pledge for the blood tests (various virus tests) of their children's mothers
2.Children of mothers who have not consented to notification of a positive result in the child's viral test (saliva test and stool test)
3.Infants of mothers whose blood tests (various virus tests) are positive.
4.children who received a blood transfusion at birth
5.Children who received antibiotics from birth to the time consent was obtained.
6.Children who have not been weaned at the time of stool collection
7.Children with serious infectious disease
8.Children with severe congenital anomalies.
9.Children who are judged as inappropriate to participate in this study under the responsibility of the principal investigator.

Exclusion criteria for definitive registration
1.children who tested positive for SARS-CoV2 in saliva test (virus test)
2.SARS-CoV2 positive in any stool test (virus test)
3.Children who are sick (fever over 37.5C, cough, nasal discharge, diarrhea, vomiting (except for vomiting after breastfeeding)) during the period of stool collection.
4.Children who received antibiotics from the time of obtaining consent until the completion of stool collection.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name Takao
Middle name
Last name Miyake
Organization Miyake Women's Clinic
Division name Director
Zip code 266-0032
Address 1-18-5 Oyumino Chuou, Midori-ku, Chiba, Chiba
TEL 043-293-3500
Email miyake@mwclin.com

Public contact
Name of contact person
1st name Arata
Middle name
Last name Yoneda
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code 101-0052
Address NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL 03-3295-1350
Homepage URL
Email cembalo@soiken.info

Sponsor
Institute Miyake Women's Clinic
Institute
Department

Funding Source
Organization Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan Physicians Association Institutional Review Board
Address Tokyo Medical Association Building 4F, 2-5, Kanda-Surugadai, Chiyoda, Tokyo, 101-0062, Japan
Tel 03-3259-6177
Email irb@nichirinnai.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 みやけウィメンズクリニック (千葉県)

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 24 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 10 Month 25 Day
Date of IRB
Anticipated trial start date
2021 Year 11 Month 24 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Changes in intestinal microflora and components before and after incubation in a culture system

Management information
Registered date
2021 Year 11 Month 24 Day
Last modified on
2021 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052684

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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