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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026101
Receipt No. R000029993
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
Date of disclosure of the study information 2017/02/13
Last modified on 2017/09/18

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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
Middle name
Last name Fumihito Hirai
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
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
Middle name
Last name Teruyuki Takeda
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
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
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
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
Anticipated trial start date
2017 Year 02 Month 14 Day
Last follow-up date
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
2017 Year 09 Month 18 Day


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

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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