UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006666 |
|---|---|
| Receipt number | R000007874 |
| Scientific Title | Evaluation of efficacy of elemental diet to inhibit the inflammation of ulcerative colitis in recovery phase |
| Date of disclosure of the study information | 2011/11/04 |
| Last modified on | 2018/01/02 21:45:05 |
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Basic information
Public title
Evaluation of efficacy of elemental diet to inhibit the inflammation of ulcerative colitis in recovery phase
Acronym
Efficacy of elemental diet to ulcerative colitis
Scientific Title
Evaluation of efficacy of elemental diet to inhibit the inflammation of ulcerative colitis in recovery phase
Scientific Title:Acronym
Efficacy of elemental diet to ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
comparison of effects of elemental diet or food to induction of remission or maintenace therapy of ulcerative colitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical activity index in day 10 to 12
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
elemental diet
Interventions/Control_2
food
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
| 15 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with ulcerative colitis without oral diet
patients with informed consent
Key exclusion criteria
Patients received with colostomy
Patients who have hypersensitivity to elental
Patients with severe DM and/or with steroid induced DM
Patients with pregnancy and/or treated with vitamin A (over 5000IU/day)
Patients with malmetabolisation of amino acid
Patients without informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1981, Kamoda, Kawagoe City, Saitama
TEL
049-228-3564
skato@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1981 Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3564
Homepage URL
skato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 04 | 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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 04 | Day |
Last modified on
| 2018 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007874
