UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the relationship between small intestinal villi and nutritional status of patients with Crohn's disease by close observation of small intestinal mucosa
Acronym	Investigation of the relationship between small intestinal villi and nutritional status of patients with Crohn's disease by close observation of small intestinal mucosa
Scientific Title	Investigation of the relationship between small intestinal villi and nutritional status of patients with Crohn's disease by close observation of small intestinal mucosa
Scientific Title:Acronym	Investigation of the relationship between small intestinal villi and nutritional status of patients with Crohn's disease by close observation of small intestinal mucosa
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between small intestinal villi and nutritional status and disease activity of patients with Crohn's disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We observe small intestinal mucosa closely, and classify villi in order(regular,irregular),density(low,high),atrophy(present,absent),shape(normal,abnormal),and reveal whether small intestinal villi are abnormal and then evaluate whether changes in these findings reflect activity or nutritional status.
Key secondary outcomes	1.We investigate small intestinal villi shape and possible presence or absence of atrophy by pathological findings. 2.We measure CDAI,albumin,CRP,and investigate relationship with small intestinal villi shape.

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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who planned small intestine endoscopy
Key exclusion criteria	1.Patients with malignant tumor 2.Patients with acute abdomen 3.Patients with serious acute inflammation 4.Patients with pregnant woman 5.Patient's general health is extremely poor,Patients who has risk for performing endoscopy such as ileus,perforation,pancreatitis,respiratory disorder,cardiovascular disorder,acquired hemophilia,stenosis,large ulcer,tumor 6.Patients on anticoagulants or who are unable to stop using anticoagulants due to other medical conditions. 7.Patients not using a bowel cleansing agent 8.Patients used to participate in this trial 9.also,patients who are judged not suitable for this trial by the doctor
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Fumihito Middle name Last name Hirai
Organization	Fukuoka University Chikushi Hospital
Division name	Department of Gastroenterology
Zip code	818-8502
Address	1-1-1 Zokumyoin Chikushino Fukuoka
TEL	092-921-1011
Email	fuhirai@cis.fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Teruyuki Middle name Last name Takeda
Organization	Fukuoka University Chikushi Hospital
Division name	Department of Gastroenterology
Zip code	818-8502
Address	1-1-1 Zokumyoin Chikushino Fukuoka
TEL	092-921-1011
Homepage URL
Email	take5times@hotmail.co.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization	Fukuoka University Chikushi Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Fukuoka University Chikushi Hospital
Address	1-1-1 Zokumyoin Chikushino Fukuoka
Tel	092-921-1011
Email	chikushirinnsho@adm.fukuoka-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	2017 Year 02 Month 13 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 01 Month 10 Day
Date of IRB	2017 Year 02 Month 09 Day
Anticipated trial start date	2017 Year 02 Month 14 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	To investigate the relationship between small intestinal villi and nutritional status of patients with Crohn's disease by close observation of small intestinal mucosa

Management information
Registered date	2017 Year 02 Month 12 Day
Last modified on	2020 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029993