UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020504 |
|---|---|
| Receipt number | R000023613 |
| Scientific Title | The Effect of enteral nutrition containing pectin "HINE E-gel" on defecation of long-term tube feeding patients. |
| Date of disclosure of the study information | 2016/01/08 |
| Last modified on | 2016/01/08 17:42:16 |
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Basic information
Public title
The Effect of enteral nutrition containing pectin "HINE E-gel" on defecation of long-term tube feeding patients.
Acronym
The Effect of enteral nutrition containing pectin on defecation.
Scientific Title
The Effect of enteral nutrition containing pectin "HINE E-gel" on defecation of long-term tube feeding patients.
Scientific Title:Acronym
The Effect of enteral nutrition containing pectin on defecation.
Region
| Japan |
Condition
Condition
Patients requiring the nutritional management using tube feeding.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of enteral nutrition containing pectin on defecation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Defecation days
Key secondary outcomes
Defecation frequency, Fecal condition, Laxative usage, Disimpaction and enema frequency
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Administered a enteral nutrition containing pectin for 4 weeks.
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Patients whose defecation are less than five days per week
(2)Patients who take the no-fiber enteral nutrition more than two weeks.
(3)Patients whose daily doses exceed the half quantity of the aim dose
(4)Patients who take enteral nutrition more than two months.
(5)Patients who provide informed consent.
(6)Patients ages 65-99 years old.
Key exclusion criteria
(1)Patients with the stomach extraction anamnesis.
(2)Patients who judged not to be appropriate for study by the medical attendant.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Maruyama |
Organization
Tanashi hospital
Division name
Surgery
Zip code
Address
3-6-1 Midori, Nishitokyo, Tokyo, Japan
TEL
042-461-2682
maruyama-tanashi@pluto.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Maruyama |
Organization
Tanashi hospital
Division name
Surgery
Zip code
Address
3-6-1 Midori, Nishitokyo, Tokyo, Japan
TEL
042-461-2682
Homepage URL
maruyama-tanashi@pluto.plala.or.jp
Sponsor or person
Institute
Tanashi hospital
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
田無病院（東京都）/Tanashi hospital（Tokyo）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 21 | 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
| 2016 | Year | 01 | Month | 08 | Day |
Last modified on
| 2016 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023613
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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