UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034788 |
|---|---|
| Receipt number | R000039669 |
| Scientific Title | Analysis of fungi in feces of patients with inflammatory bowel disease |
| Date of disclosure of the study information | 2018/11/06 |
| Last modified on | 2019/05/07 14:20:00 |
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Basic information
Public title
Analysis of fungi in feces of patients with inflammatory bowel disease
Acronym
Analysis of fungi in feces of patients with inflammatory bowel disease
Scientific Title
Analysis of fungi in feces of patients with inflammatory bowel disease
Scientific Title:Acronym
Analysis of fungi in feces of patients with inflammatory bowel disease
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is aimed to clarify the effect of fecal fungus on the pathology of IBD.
Basic objectives2
Others
Basic objectives -Others
The relationship between pathogenesis of inflammatory bowel disease and fecal fungus
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composition of fecal fungi in patients with IBD, differences in IBC patients versus fecal fungus composition of healthy volunteers
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
From March 2012 until October 2017 Shiga Medical University Hospital If you have a history of inflammatory bowel disease who has a history of gastroenterology, or has hospitalized cases, and who does not have inflammatory bowel disease
Key exclusion criteria
Those who received antibiotics or intestinal administration within 1 month from the time of infection.
A person whose research researcher judged unsuitable as a subject.
Those who requested suspension of samples or information to the same research.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nishida |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
520-2192
Address
Seta Tsukinowa, Otsu, Shiga, Japan
TEL
077-548-2217
atsuda@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Nishida |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
520-2192
Address
Seta Tsukinowa, Otsu, Shiga, Japan
TEL
077-548-2217
Homepage URL
atsuda@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Shiga University of Medical Science
Address
Tsukinowa, Seta, Otsu
Tel
077-548-3576
hqrec@belle.shiga-med.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
| 2018 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
58
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
| 2018 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Method>
Ulcerative colitis, Crohn's disease and stool specimens preserved for clinical studies using stool specimens of healthy subjects. It has been acquired using consent form and instruction manual for each clinical study. Consent form and instructions are acquired in case groups(ulcerative colitis, Crohn's disease)and control group, respectively.
<Selection criteria>
From March 2012 until October 2017 Shiga Medical University Hospital If you have a history of inflammatory bowel disease who has a history of gastroenterology, or has hospitalized cases, and who does not have inflammatory bowel disease.
Those over 20 years old.
<Observation and inspection items>
Clinical findings(disease score)at the time of sample collection, blood test findings (Hb, CRP, ESR, Alb), endoscopic findings, patient age, sex, disease duration, medical history, treatment history.
In both items, data closest to the time of fecal sampling is collected from the medical record.
For the data of the control group, only those which can be confirmed on medical record among the above items are collected.
Management information
Registered date
| 2018 | Year | 11 | Month | 06 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039669
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
