UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the relation between malnutrition and prognosis in patients with inflammatory bowel disease(IBD).
Title of the study (Brief title)	Malnutrition and IBD.
Region	Japan

Condition
Condition	Inflammatory bowel disease (IBD)
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the relationship between malnutrition and the prognosis in patients with IBD.
Basic objectives2	Others
Basic objectives -Others	Incidence
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in nutrition status, skeletal muscle mass, and bone mineral density.
Key secondary outcomes	response rate recurrence rate adverse event

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with IBD under treatment.
Key exclusion criteria	1. Patients who have severe physical dysfunction. 2. Patients who are judged as being inappropriate for this study by their medical doctor.
Target sample size	90

Research contact person
Name of lead principal investigator	Tomoo Nakagawa
Organization	Chiba University Hospital
Division name	Department of gastroenterology
Address	1-8-1 Inohana, Chuo-Ku, Chiba city
TEL	043-222-7171
Email	tom20852@hospital.chiba-u.jp

Public contact
Name of contact person	Tomoo Nakagawa
Organization	Chiba University Hospital
Division name	Department of gastroenterology
Address	1-8-1 Inohana, Chuo-Ku, Chiba city
TEL	043-222-7171
Homepage URL
Email	tom20852@hospital.chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba 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	2016 Year 12 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 01 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	As prospective study, 1-4 are assessed. 1. Height, Body Weight, and BMI 2. Laboratory test 3. skeletal muscle mass 4. Bone mineral density

Management information
Registered date	2016 Year 12 Month 01 Day
Last modified on	2016 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028875