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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-UMIN000018745 |
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Date of registration:
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01/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy
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Scientific title:
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The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy - The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy |
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Date of first enrolment:
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2015/09/01 |
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Target sample size:
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40 |
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Recruitment status: |
Pending |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021625 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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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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Hidemi Gtoh |
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Address:
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Department of Gastroenterology and hepatology
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Telephone:
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+81-52-744-2164 |
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Email:
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hgoto@med.nagoya-u.ac.jp |
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Affiliation:
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Nagoya University Graduate School of Medicine Nagoya University Graduate School of Medicine |
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Name:
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Tsunaki Sawada |
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Address:
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65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
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Telephone:
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+81-52-741-2172 |
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Email:
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t.sawada@med.nagoya-u.ac.jp |
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Affiliation:
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Nagoya University Graduate School of Medicine Department of Gastroenterology and Hepatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1.Proctitis 2.Fluminating type 3.Severe ulcer,massive bleeding,perforation,toxic megacolon 4.Severe conplication 5.Allergic disease 6.Patients who reciept infusion of anti-TNF alpha antibody within 6 months 7.Pregnancy
Age minimum:
15years-old
Age maximum:
75years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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ulcerative colitis
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Intervention(s)
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Administration of Infliximab and enteral nutrition
Administration of Infliximab
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Primary Outcome(s)
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Diffarence of remission rate or improvement rate between two group
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Secondary Outcome(s)
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Difference of IFX trough between two group. Relationship of IFX trough and serum albmin,and improvement rate.
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Source(s) of Monetary Support
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Nagoya University Graduate School of Medicine
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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