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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 22 July 2019
Main ID:  JPRN-UMIN000008043
Date of registration: 28/05/2012
Prospective Registration: No
Primary sponsor: The Jikei University School of Medicine Division of Gastroenterology and Hepatology
Public title: The influence of medication for Crohn's disease on serological response to the influenza vaccination
Scientific title: The influence of medication for Crohn's disease on serological response to the influenza vaccination - Influence of Crohn's disease medication on influenza vaccination
Date of first enrolment: 2012/05/01
Target sample size: 150
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008785
Study type:  Interventional
Study design:  Parallel Non-randomized  
Phase:  Phase IV
Countries of recruitment
Japan
Contacts
Name:     Masayuki Saruta
Address:  3-25-8 Nishi-shinbashi, Minato-ku, Tokyo Japan
Telephone: 03-3433-1111
Email:
Affiliation:  The Jikei University School of Medicine Division of Gastroenterology and Hepatology
Name:     Masayuki Saruta
Address:  3-25-8 Nishi-shinbashi, Minato-ku, Tokyo Japan
Telephone: 03-3433-1111
Email:
Affiliation:  The Jikei University School of Medicine Division of Gastroenterology and Hepatology
Key inclusion & exclusion criteria
Inclusion criteria:
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.


Age minimum: 16years-old
Age maximum: 60years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
Influenza Vaccination to Crohn's disease patients treated with Infliximab

Influenza Vaccination to Crohn's disease patients treated with Elemental diet
Influenza Vaccination to patients with upper-alimentary tract disorders (Disease-control)
Primary Outcome(s)
Response Rate of post-vaccination antibody titters against Influenza B/Brisbane.
Secondary Outcome(s)
1;Response Rate of post-vaccination antibody titters against Influenza A/California,Victoria.
2; CDAI scores at each observation period
Secondary ID(s)
Source(s) of Monetary Support
self funding
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed: 31/12/2012
URL:
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