UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010293 |
|---|---|
| Receipt number | R000012053 |
| Scientific Title | Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy |
| Date of disclosure of the study information | 2013/03/21 |
| Last modified on | 2013/11/13 22:55:18 |
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Basic information
Public title
Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy
Acronym
Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy
Scientific Title
Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy
Scientific Title:Acronym
Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of nutrition therapy in patients with Crohn's disease controlled by maintenance Infliximab therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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.)
Key secondary outcomes
1)CRP concentration in Blood
2)QOL assessment by SF-36
Other
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
In the group of non-nutritional therapy is carried out aggressive nutritional intervention is not performed, and only the normal diet
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motohiro Esaki |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Medical and Clinical Science
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5261
mesaki@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Ikegami |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Medical and Clinical Science
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5261
Homepage URL
kikegami@intmed2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Oita Red Cross Hospital
Takano Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州大学病院（福岡県）、大分赤十字病院（大分県）、高野病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2009 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 21 | Day |
Last modified on
| 2013 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012053
