UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046155 |
|---|---|
| Receipt number | 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 | 2023/05/26 20:12:43 |
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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
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
cembalo@soiken.info
Sponsor or person
Institute
Miyake Women's Clinic
Institute
Department
Personal name
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
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
9
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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 24 | 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
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
| 2023 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052684
