UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012958 |
|---|---|
| Receipt number | R000014855 |
| Scientific Title | FGIDs and Intestinal Spirochetosis |
| Date of disclosure of the study information | 2014/01/27 |
| Last modified on | 2014/01/25 17:24:57 |
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Basic information
Public title
FGIDs and Intestinal Spirochetosis
Acronym
FGIDs and Intestinal Spirochetosis
Scientific Title
FGIDs and Intestinal Spirochetosis
Scientific Title:Acronym
FGIDs and Intestinal Spirochetosis
Region
| Japan |
Condition
Condition
FGIDs
Intestinal Spirochetosis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the prevalence of Spirochetosis in Japan.
Basic objectives2
Others
Basic objectives -Others
To assess the symptom and endscopic findings of Intestinal Spirochetosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between FGIDs and the prevalence of Spirochetosis.
Key secondary outcomes
1.Endscopic findings
2.Histological findings
3.Bacterial strain
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who are more than 15 years old or their representatives (both the patient and their representative if the patient is between 15 and 20 years of age) from whom written informed consent is obtained.
2.Patients who can provide background factors:sex,age,past medical history,famiry history and life history.
3.Patients who can provide pathological diagnosis and histopathology.
Key exclusion criteria
1.Patients for whom it has been determined by the principal investigator that there will be complicating issues with the patient participating in the study.
2.Patiants from whom written informed consent cannot be obtained.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kato Mototsugu |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
Kita14-jo nishi 5-chome, kitaku, Sapporo, Hokkaido
TEL
011-716-1211
m-kato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mabe katsuhiro |
Organization
Hokkaido University Hospital
Division name
Division of Endscopy
Zip code
Address
Kita 14-jo nishi 5-chome, kitaku, Sapporo, Hokkaido
TEL
011-716-1211
Homepage URL
katsumabe@me.com
Sponsor or person
Institute
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterlogy and Hepatology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 01 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Prospective study
Management information
Registered date
| 2014 | Year | 01 | Month | 25 | Day |
Last modified on
| 2014 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014855
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
