UMIN-CTR Clinical Trial

Basic information
Public title	The influence of medication for Crohn's disease on serological response to the influenza vaccination
Acronym	Influence of Crohn's disease medication on influenza vaccination
Scientific Title	The influence of medication for Crohn's disease on serological response to the influenza vaccination
Scientific Title:Acronym	Influence of Crohn's disease medication on influenza vaccination
Region	Japan

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

Objectives
Narrative objectives1	To clarify the effect of Crohn's disease-medications on the serological response to the influenza vaccine
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	Response Rate of post-vaccination antibody titters against Influenza B/Brisbane.
Key secondary outcomes	1;Response Rate of post-vaccination antibody titters against Influenza A/California,Victoria. 2; CDAI scores at each observation period

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	3
Purpose of intervention	Prevention
Type of intervention	Medicine Vaccine
Interventions/Control_1	Influenza Vaccination to Crohn's disease patients treated with Infliximab
Interventions/Control_2	Influenza Vaccination to Crohn's disease patients treated with Elemental diet
Interventions/Control_3	Influenza Vaccination to patients with upper-alimentary tract disorders (Disease-control)
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients of Crohn's disease with Infliximab treatments or elemental diet therapy (>1 year) who want to receive Influenza vaccination 2)Patients of upper alimentary tract disorders without crohn's disease and ulcerative colitis who have not been treated with steroid, immunomodulators, anti-TNF reagents, and elemental diet within 16weeks.(Disease Control)
Key exclusion criteria	1)Patients who have been treated with Cyclosporin, Tacrolimus, Methotrexate, Steroids, total parental nutrition,granulocyte/monocyte apheresis therapy within 16 weeks. 2) Patients with severe infection or its complications within 1 year. 3) Patients with severe heart, kidney,liver,blood disease or developmental disorders. 4) Patients with allergic disease (Generalized rash etc.) 5) Patients with history of convulsion. 6) Patients diagnosed as an immune deficiency. 7) Patients with respiratory disease (interstitial pneumonia, bronchial asthma etc.) 8) Patients with allergy against ingredients of Influenza vaccine, hen's egg,or ingredients of hen. 9) Patients with drug or alcohol dependence or its history 10) Patients participated other clinical trial within 16 weeks. 11)Other patients judged as inappropriate bu the physician. 12) Patients received anti-TNF agents within 1 year (Only Elemental diet Groups) 13) Patients do not desire to receive Influenza vaccination.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masayuki Saruta
Organization	The Jikei University School of Medicine
Division name	Division of Gastroenterology and Hepatology
Zip code
Address	3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Email

Public contact
Name of contact person	1st name Middle name Last name Masayuki Saruta
Organization	The Jikei University School of Medicine
Division name	Division of Gastroenterology and Hepatology
Zip code
Address	3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Homepage URL
Email

Sponsor
Institute	The Jikei University School of Medicine Division of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	東京慈恵会医科大学（東京都）、昭和大学（東京都）虎ノ門病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 28 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	Terminated
Date of protocol fixation	2012 Year 02 Month 06 Day
Date of IRB	2011 Year 12 Month 09 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2012 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 05 Month 28 Day
Last modified on	2019 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008785