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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000048453 |
Receipt No. | 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 | 2022/07/25 |
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 |
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Condition | |||
Condition | Asthma, atopic dermatitis, urticaria | ||
Classification by specialty |
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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 |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Juntendo University |
Institute | |
Department |
Funding Source | |
Organization | Metagen Therapeutics, Inc
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055218 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |