UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective cohort study of medication for inflammatory bowel disease
Title of the study (Brief title)	Prospective cohort study of medication for inflammatory bowel disease
Region	Japan

Condition
Condition	inflammatory bowel disease
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to evaluate the efficacy and safety of patients treated with inflammatory bowel disease for ulcerative colitis and Crohn's disease patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of clinical efficacy at 8 weeks after initiation of treatment
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Ministry of Health, Labor and Welfare Survey Study on Intractable Inflammatory Bowel Disease Disorder Patients newly intervening therapeutically among cases diagnosed as ulcerative colitis or Crohn's disease according to diagnostic criteria. 2 Patient who obtained consent of this study. 3 Patients over 16 years of age.
Key exclusion criteria	1 patients suspected of having intestinal inflammation other than UC and Crohn's disease (infectious enteritis, etc.). 2 Patients with symptomatic digestive tract stenosis. 3 Patient planning resection of colon. 4 Severe infections Patients with complications. 5 Other patients who judged that the physician in charge is inappropriate to incorporate into this study.
Target sample size	600

Research contact person
Name of lead principal investigator	Makoto Naganuma
Organization	School of Medicine, Keio University
Division name	Gastroenterology and Hepatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	nagamakoto@keio.jp

Public contact
Name of contact person	Makoto Naganuma
Organization	School of Medicine, Keio University
Division name	Gastroenterology and Hepatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	nagamakoto@keio.jp

Sponsor
Institute	School of Medicine, Keio University
Institute
Department

Funding Source
Organization	School of Medicine, Keio University
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	2017 Year 07 Month 06 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 07 Day
Anticipated trial start date	2017 Year 07 Month 06 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	rate of response and clinical remission, frequency and type of side effects. Albumin, ESR, CRP, WBC, Plt (albumin, CRP, WBC, Plt), the transition of disease activity (partial Mayo score, CDAI), symptomatic transition (stool frequency, nocturia diarrhea, bloody stool, abdominal pain, fever, general evaluation) , Fecal occult blood), transition of endoscopic findings (Mayo score, activity). Side effects, presence or absence of adverse events.

Management information
Registered date	2017 Year 07 Month 05 Day
Last modified on	2017 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032158