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Main
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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. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000008043 |
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Date of registration:
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28/05/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The influence of medication for Crohn's disease on serological response to the influenza vaccination
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Scientific title:
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The influence of medication for Crohn's disease on serological response to the influenza vaccination - Influence of Crohn's disease medication on influenza vaccination |
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Date of first enrolment:
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2012/05/01 |
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Target sample size:
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150 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008785 |
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Study type:
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Interventional |
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Study design:
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Parallel Non-randomized
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Phase:
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Phase IV
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Countries of recruitment
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Japan
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Contacts
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Name:
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Masayuki Saruta |
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Address:
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3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
Japan |
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Telephone:
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03-3433-1111 |
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Email:
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Affiliation:
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The Jikei University School of Medicine Division of Gastroenterology and Hepatology |
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Name:
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Masayuki Saruta |
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Address:
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3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
Japan |
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Telephone:
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03-3433-1111 |
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Email:
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Affiliation:
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The Jikei University School of Medicine Division of Gastroenterology and Hepatology |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Crohn's disease
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Intervention(s)
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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)
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Primary Outcome(s)
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Response Rate of post-vaccination antibody titters against Influenza B/Brisbane.
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Secondary Outcome(s)
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1;Response Rate of post-vaccination antibody titters against Influenza A/California,Victoria. 2; CDAI scores at each observation period
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Source(s) of Monetary Support
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self funding
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Ethics review
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Status: YES
Approval date: 09/12/2011
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2012 |
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URL:
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