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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016792
Receipt No. 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

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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
Email 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
Email nakano-m@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019493

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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