UMIN-CTR Clinical Trial

Basic information
Public title	The usefulness of fecal markers as predictive markers for induction therapy for patients with ulcerative colitis
Acronym	The usefulness of fecal markers for patients with ulcerative colitis
Scientific Title	The usefulness of fecal markers as predictive markers for induction therapy for patients with ulcerative colitis
Scientific Title:Acronym	The usefulness of fecal markers for patients with ulcerative colitis
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the best choice of fecal markers after starting induction therapy, by evaluating the changes in the values of each marker according to the changes in the sympton and endoscopic findings of UC patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Remission rate, The change of fecal markers
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient who will receive colonoscopy and additional medication Patients who agree the participation in this study from due to the published information Patient who can collect feacal material
Key exclusion criteria	Patients with colectomy Patients with malignant disease Patients during pregnancy
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Sakiko Middle name Last name Hiraoka
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7219
Email	sakikoh@cc.okayama-.u.ac.jp

Public contact
Name of contact person	1st name Sakiko Middle name Last name Hiraoka
Organization	Okayama University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7219
Homepage URL
Email	sakikoh@cc.okayama-.u.ac.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Biochemical Research Laboratory-I, Eiken Chemical Co.,Ltd. and Self-raising
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1 shikata-cho
Tel	0862357552
Email	mae6605@adm.okayama-u.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 01 Month 01 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	Main results already published
Date of protocol fixation	2017 Year 02 Month 14 Day
Date of IRB	2017 Year 02 Month 03 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Subsequent clinical symptoms and fecal marker of patients with additional treatment are examined and the relationship with response to therapy is analyzed.

Management information
Registered date	2017 Year 12 Month 30 Day
Last modified on	2021 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029123