UMIN-CTR Clinical Trial

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
Last 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
Email	atsuda@belle.shiga-med.ac.jp

Public contact
1st 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
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)

IRB Contact (For public release)
Organization	Shiga University of Medical Science
Address	Tsukinowa, Seta, Otsu
Tel	077-548-3576
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039669