UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016792 |
|---|---|
| Receipt number | R000019493 |
| Scientific Title | Clinical investigations of the therapeutic effect of an elemental diet for and the blood amino acid level changes of patients with inflammatory bowel disease |
| Date of disclosure of the study information | 2015/03/14 |
| Last modified on | 2017/03/14 17:40:11 |
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Basic information
Public title
Clinical investigations of the therapeutic effect of an elemental diet for and the blood amino acid level changes of patients with inflammatory bowel disease
Acronym
Clinical investigations of the therapeutic effect of an elemental diet for and the blood amino acid level changes of patients with inflammatory bowel disease
Scientific Title
Clinical investigations of the therapeutic effect of an elemental diet for and the blood amino acid level changes of patients with inflammatory bowel disease
Scientific Title:Acronym
Clinical investigations of the therapeutic effect of an elemental diet for and the blood amino acid level changes of patients with inflammatory bowel disease
Region
| Japan |
Condition
Condition
Crohn's disease, Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial aims to clarify the correlation between the therapeutic effect of the administration of an ED (Elental) and changes in the blood amino acid levels of patients with IBD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A) Change in disease score (CDAI for CD; DAI for UC) before versus after the 12 weeks of treatment
B) Change in blood amino acid levels before versus after the 12 weeks of treatment
Key secondary outcomes
A) Influences on quality of life
B) Changes in immunoregulatory therapy
C) Hematological, blood biochemical, and nutritional indices
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
2 packs of Elental administered in addition to the current dose (>900 kcal/day of the total dose)
Interventions/Control_2
Control group (a group of IBD patients whose current dose will be maintained)
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A) Patients aged =>16 years who are definitively diagnosed with CD or UC.
B) CD: Patients in the mildly to moderately active stage with a 150 > CDAI < 221.UC: Patients in the mildly to moderately active stage with a 3 > DAI < 11.
C) Patients with stable disease and an Alb < 3.8 g/dL.
D) Patients who provided written consent to participate in the trial.
* In the case of a minor, guardian consent shall be required.
Key exclusion criteria
A) Cannot continue receiving Elental (ED-intolerant, severe diabetes, receiving high-dose steroids, suspected of having abnormal glucose or abnormal amino acid metabolism);
B) Less than 18 years of age and lacking guardian consent; or
C) Judged by the principal investigator as inappropriate subjects.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Nakano |
Organization
Dokkyo Medical University
Division name
Department of Gastroenterology
Zip code
Address
880 Kitakobayashi, Mibu-machi, Simotsuga-gun Tochigi 321-0293
TEL
0282-86-1111
nakano-m@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu Nakano |
Organization
Dokkyo Medical University
Division name
Department of Gastroenterology
Zip code
Address
880 Kitakobayashi, Mibu-machi, Simotsuga-gun Tochigi 321-0293
TEL
0282-86-1111
Homepage URL
nakano-m@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | 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
| 2015 | Year | 03 | Month | 13 | Day |
Last modified on
| 2017 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019493
