UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of elemental diet, Elental on maintenance therapy of Crohn's disease after remission with anti-TNFa antibody.(non-randomized control study)
Title of the study (Brief title)	Additional Power of Elemental Diet (Elental)on Maintenance Biologics therapy in Crohn's Disease. (ADORE Study)
Region	Japan

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

Objectives
Narrative objectives1	To confirm the usefulness of elemental diet combination with biologics treatment for maintenance remission of Crohn's disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The occurrence of relapse (Relapse was defined by: (1) increase in CDAI of at least 70 points from the baseline score with a total score of at least 220, (2) shortening of biologics dosing interval (3) introduction of a new treatment for active Crohn's disease)
Key secondary outcomes	Response rate, safety assesment Others

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Patients take >=900 kcal/day elemental diet, combination with scheduled biologics treatment.
Interventions/Control_2	Patients dose not use any enteral diet therapy, combination with scheduled biologics treatment.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Moderate to severe (CDAI 220-400) patients. Patients who are introduced anti-TNFa antibody as induction therapy. Patients approving the study consent.
Key exclusion criteria	Patients in 16 weeks after last biologics dosing or after bowel resection. Patients with stoma. Parenteral nutrition dependent patients with short bowel syndrome or others. Biologics intolerance. Patients judged as inadequate at the discretion of physicians.
Target sample size	100

Research contact person
Name of lead principal investigator	Toshiyuki Matsui
Organization	Fukuoka University Chikushi Hospital
Division name	Depertment of Gastroenterology
Address	1-1-1 Zokumyoin Chikushino, Fukuoka, JAPAN
TEL	092-921-1011
Email	syokaki@fukuoka-u.ac.jp

Public contact
Name of contact person	Fumihito Hirai
Organization	Fukuoka University Chikushi Hospital
Division name	Depertment of Gastroenterology
Address	1-1-1 Zokumyoin Chikushino, Fukuoka, JAPAN
TEL	092-921-1011
Homepage URL
Email	syokaki@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ajinomoto Pharmaceuticals Co.,Inc.
Organization
Division
Category of Funding Organization	Profit organization
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	福岡大学筑紫病院（福岡県）、九州大学（福岡県）、福岡大学（福岡県）、福岡山王病院（福岡県）、九州中央病院（福岡県）、福岡赤十字病院（福岡県）、浜の町病院（福岡県）、千鳥橋病院（福岡県）、久留米大学（福岡県）、くるめ病院（福岡県）、戸畑共立病院（福岡県）、産業医科大学（福岡県）、佐賀大学（佐賀県）、大分赤十字病院（大分県）、長崎大学（長崎県）、井上病院（長崎県）、聖フランシスコ病院（長崎県）、長崎市民病院（長崎県）、長崎原爆病院（長崎県）、光晴会病院（長崎県）、高野病院（熊本県）、済生会熊本病院（熊本県）、今村病院（鹿児島県）、宮崎大学（宮崎県）、古賀総合病院（宮崎県）、琉球大学（沖縄県）、浦添総合病院（沖縄県）、中頭病院（沖縄県）、那覇市立病院（沖縄県）

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 10 Month 01 Day
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
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

Management information
Registered date	2013 Year 01 Month 16 Day
Last modified on	2016 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011467