UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficacy of elemental diet to inhibit the inflammation of ulcerative colitis in recovery phase
Title of the study (Brief title)	Efficacy of elemental diet to ulcerative colitis
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	comparison of effects of elemental diet or food to induction of remission or maintenace therapy of ulcerative colitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical activity index in day 10 to 12
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	elemental diet
Interventions/Control_2	food
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	15 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with ulcerative colitis without oral diet patients with informed consent
Key exclusion criteria	Patients received with colostomy Patients who have hypersensitivity to elental Patients with severe DM and/or with steroid induced DM Patients with pregnancy and/or treated with vitamin A (over 5000IU/day) Patients with malmetabolisation of amino acid Patients without informed consent
Target sample size	40

Research contact person
Name of lead principal investigator	Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Address	1981, Kamoda, Kawagoe City, Saitama
TEL	049-228-3564
Email	skato@saitama-med.ac.jp

Public contact
Name of contact person	Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Address	1981 Kamoda, Kawagoe City, Saitama, Japan
TEL	049-228-3564
Homepage URL
Email	skato@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical University
Organization
Division
Category of Funding Organization	Other
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	2011 Year 11 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 04 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 11 Month 04 Day
Last modified on	2018 Year 01 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007874