UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048453 |
|---|---|
| Receipt number | R000055218 |
| Scientific Title | Casecontrol studies:Investigation of the relationship between substances derived from intestinal bacteria and allergic diseases, and development of basic control technologies |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2023/07/26 16:18:09 |
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Basic information
Public title
Casecontrol studies:Investigation of the relationship between substances derived from intestinal bacteria and allergic diseases, and development of basic control technologies
Acronym
Casecontrol studies:Investigation of the relationship between substances derived from intestinal bacteria and allergic diseases, and development of basic control technologies
Scientific Title
Casecontrol studies:Investigation of the relationship between substances derived from intestinal bacteria and allergic diseases, and development of basic control technologies
Scientific Title:Acronym
Casecontrol studies:Investigation of the relationship between substances derived from intestinal bacteria and allergic diseases, and development of basic control technologies
Region
| Japan |
Condition
Condition
Asthma, atopic dermatitis, urticaria
Classification by specialty
| Pneumology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether substances derived from intestinal bacteria are involved in the development or exacerbation of allergic diseases
Basic objectives2
Others
Basic objectives -Others
Elucidation of the relationship between allergies and intestinal bacteria
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the relationship between components collected from blood and substances derived from intestinal bacteria.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Those with allergic diseases (asthma, atopic dermatitis, urticaria)
2 Adults over 18 years of age
3 Gender is not required
4 Those who go to the outpatient clinic
5 Those who, after receiving sufficient explanations for participating in this research, obtain written consent of the research subject of their own free will after sufficient understanding.
Key exclusion criteria
(1) Those who are involved in other autoimmune diseases other than allergic diseases (asthma, atopic dermatitis, urticaria)
(2) Those who have a history of cancer of the digestive system, or those who are currently receiving treatment or medication for the disease
(3) Those who have digestive disorders such as irritable bowel syndrome and inflammatory bowel disease
(4) Those who have taken or continued to use antibacterial drugs within 3 months before the explanation of consent
(5) Those who suffer from serious cerebrovascular disease, heart disease, liver disease, kidney disease, digestive disorder, infectious disease that requires notification, etc.
(6) Those who have a history of major surgery on the digestive system, such as gastrectomy, gastrointestinal sutures, intestinal resection, etc.
(7) Those who have significant abnormalities in blood pressure measurement, anthropometry, and blood test
(8) Lactating women, pregnant women, or anyone who may be pregnant
(9) Other persons who are judged by the Principal Investigator to be inappropriate as Research Subjects
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Dai |
| Middle name | |
| Last name | Ishikawa |
Organization
Juntendo University Hospital
Division name
Gastroenterology
Zip code
113-0033
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
TEL
03-3813-3111
dai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Maruyama |
Organization
Juntendo University Hospital
Division name
Gastroenterology
Zip code
113-0033
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
TEL
03-3813-3111
Homepage URL
t-maruyama@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Metagen Therapeutics, Inc
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanagawa Institute of Industrial Science and Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
Tel
03-3814-5672
hongo-rinri@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special mention
Management information
Registered date
| 2022 | Year | 07 | Month | 25 | Day |
Last modified on
| 2023 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055218
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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