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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034788
Receipt No. R000039669
Official scientific title of the study Analysis of fungi in feces of patients with inflammatory bowel disease
Date of disclosure of the study information 2018/11/06
Last modified on 2018/11/06

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Basic information
Official scientific title of the study Analysis of fungi in feces of patients with inflammatory bowel disease
Title of the study (Brief title) 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 Atsushi Nishida
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Address Seta Tsukinowa, Otsu, Shiga, Japan
TEL 077-548-2217
Email atsuda@belle.shiga-med.ac.jp

Public contact
Name of contact person Atsushi Nishida
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Address Seta Tsukinowa, Otsu, Shiga, Japan
TEL 077-548-2217
Homepage URL
Email atsuda@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 03 Month 07 Day
Anticipated trial start date
2018 Year 03 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039669

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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