UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical investigations of the therapeutic effect of an elemental diet for and the blood amino acid level changes of patients with inflammatory bowel disease
Title of the study (Brief title)	Clinical investigations of the therapeutic effect of an elemental diet for and the blood amino acid level changes of patients with inflammatory bowel disease
Region	Japan

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

Objectives
Narrative objectives1	This trial aims to clarify the correlation between the therapeutic effect of the administration of an ED (Elental) and changes in the blood amino acid levels of patients with IBD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A) Change in disease score (CDAI for CD; DAI for UC) before versus after the 12 weeks of treatment B) Change in blood amino acid levels before versus after the 12 weeks of treatment
Key secondary outcomes	A) Influences on quality of life B) Changes in immunoregulatory therapy C) Hematological, blood biochemical, and nutritional indices

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	2 packs of Elental administered in addition to the current dose (>900 kcal/day of the total dose)
Interventions/Control_2	Control group (a group of IBD patients whose current dose will be maintained)
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	A) Patients aged =>16 years who are definitively diagnosed with CD or UC. B) CD: Patients in the mildly to moderately active stage with a 150 > CDAI < 221.UC: Patients in the mildly to moderately active stage with a 3 > DAI < 11. C) Patients with stable disease and an Alb < 3.8 g/dL. D) Patients who provided written consent to participate in the trial. * In the case of a minor, guardian consent shall be required.
Key exclusion criteria	A) Cannot continue receiving Elental (ED-intolerant, severe diabetes, receiving high-dose steroids, suspected of having abnormal glucose or abnormal amino acid metabolism); B) Less than 18 years of age and lacking guardian consent; or C) Judged by the principal investigator as inappropriate subjects.
Target sample size	40

Research contact person
Name of lead principal investigator	Masakazu Nakano
Organization	Dokkyo Medical University
Division name	Department of Gastroenterology
Address	880 Kitakobayashi, Mibu-machi, Simotsuga-gun Tochigi 321-0293
TEL	0282-86-1111
Email	nakano-m@dokkyomed.ac.jp

Public contact
Name of contact person	Masakazu Nakano
Organization	Dokkyo Medical University
Division name	Department of Gastroenterology
Address	880 Kitakobayashi, Mibu-machi, Simotsuga-gun Tochigi 321-0293
TEL	0282-86-1111
Homepage URL
Email	nakano-m@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Dokkyo Medical 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	2015 Year 03 Month 14 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 10 Month 01 Day
Anticipated trial start date	2010 Year 10 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 13 Day
Last modified on	2017 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019493