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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030641
Receipt No. R000029123
Scientific Title The usefulness of fecal markers as predictive markers for induction therapy for patients with ulcerative colitis
Date of disclosure of the study information 2018/01/01
Last modified on 2017/12/30

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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
Middle name
Last name Sakiko Hiraoka
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Gastroenterology and Hepatology
Zip code
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
Middle name
Last name Sakiko Hiraoka
Organization Okayama University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
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
2017 Year 12 Month 30 Day


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

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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