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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: 2 April 2019
Main ID:  JPRN-UMIN000010293
Date of registration: 21/03/2013
Prospective Registration: No
Primary sponsor: Graduate School of Medical Sciences, Kyushu University
Public title: Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy
Scientific title:
Date of first enrolment: 2009/12/19
Target sample size: 80
Recruitment status: Recruiting
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012053
Study type:  Interventional
Study design:  Parallel Non-randomized  
Phase:  Not applicable
Countries of recruitment
Japan
Contacts
Name: Koji Ikegami   
Address:  Maidashi 3-1-1, Higashi-ku, Fukuoka Japan
Telephone: 092-642-5261
Email: kikegami@intmed2.med.kyushu-u.ac.jp
Affiliation:  Graduate School of Medical Sciences, Kyushu University Medical and Clinical Science
Name: Motohiro Esaki   
Address:  Maidashi 3-1-1, Higashi-ku, Fukuoka Japan
Telephone: 092-642-5261
Email: mesaki@intmed2.med.kyushu-u.ac.jp
Affiliation:  Graduate School of Medical Sciences, Kyushu University Medical and Clinical Science
Key inclusion & exclusion criteria
Inclusion criteria: Patients with Crohn's disease in remission underwent infliximab maintenance therapy that meets all of the following criteria:
It is intended for.
(1) Administered every 8 weeks infliximab, the patient is less than or equal to 150 CDAI
(2) Patient age at the time of registrationis at least 20 years of age, consent has been obtained for participation in this study

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
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
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
Primary Outcome(s)
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.)
Secondary Outcome(s)
1)CRP concentration in Blood
2)QOL assessment by SF-36
Other
Secondary ID(s)
Source(s) of Monetary Support
None
Secondary Sponsor(s)
Oita Red Cross Hospital Takano Hospital
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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