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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-UMIN000010293 |
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Date of registration:
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21/03/2013 |
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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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Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy
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Scientific title:
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Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy - Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy |
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Date of first enrolment:
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2009/12/19 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012053 |
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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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Not applicable
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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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Koji Ikegami |
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Address:
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Maidashi 3-1-1, Higashi-ku, Fukuoka
Japan |
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Telephone:
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092-642-5261 |
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Email:
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kikegami@intmed2.med.kyushu-u.ac.jp |
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Affiliation:
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Graduate School of Medical Sciences, Kyushu University Medical and Clinical Science |
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Name:
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Motohiro Esaki |
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Address:
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Maidashi 3-1-1, Higashi-ku, Fukuoka
Japan |
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Telephone:
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092-642-5261 |
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Email:
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mesaki@intmed2.med.kyushu-u.ac.jp |
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Affiliation:
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Graduate School of Medical Sciences, Kyushu University Medical and Clinical Science |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: This is true even if one of the following are excluded from the scope. (1)Patients with bowel obstruction (2)Patients with short bowel syndrome (3)Patients with advanced liver and kidney failure (4)Patients with abnormal glucose metabolism, such as severe diabetes (5)Patients with congenital disorders of amino acid metabolism (6)Patients with milk protein allergy (7)Patients with stoma (8) Other patients attending physician has determined inappropriate test
Age minimum:
20years-old
Age maximum:
Not applicable
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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Infliximab maintenance therapy for 48 weeks in, Racol daily nutritional interventions during the study period as a target intake of 800kcal per day, in the implementation group nutrition therapy is used in conjunction with a diet and Racol.
In the group of non-nutritional therapy is carried out aggressive nutritional intervention is not performed, and only the normal diet
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Primary Outcome(s)
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Cumulative non-relapse rate at 48 weeks (Definition of relapse; as if CDAI was more than 150 and had increased more than 70 from the previous value. Cases of relapse were defined as patients who fulfill the definition of relapse at least once in determination of CDAI at every four weeks.)
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Secondary Outcome(s)
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1)CRP concentration in Blood 2)QOL assessment by SF-36 Other
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Source(s) of Monetary Support
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None
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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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