UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013610 |
|---|---|
| Receipt number | R000015856 |
| Scientific Title | A study on the safety of concentrated liquid diet containing pectin administered by gravity administration via naso-gastric tube |
| Date of disclosure of the study information | 2014/04/15 |
| Last modified on | 2015/09/15 12:16:00 |
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Basic information
Public title
A study on the safety of concentrated liquid diet containing pectin administered by gravity administration via naso-gastric tube
Acronym
A study on the safety of gravity administration of concentrated liquid diet containing pectin
A study on the safety of concentrated liquid diet containing pectin administered by gravity administration
Scientific Title
A study on the safety of concentrated liquid diet containing pectin administered by gravity administration via naso-gastric tube
Scientific Title:Acronym
A study on the safety of gravity administration of concentrated liquid diet containing pectin
A study on the safety of concentrated liquid diet containing pectin administered by gravity administration
Region
| Japan |
Condition
Condition
Patients requiring the nutritional management using naso-gastric tube
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of gastrointestinal symptoms during the gravity administration of novel liquid diet, HINE E-gel, via naso-gastric tube and to observe the effects of nutritional supplementation of the diet
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of gastrointestinal symptoms
Total number of defecation and frequency of diarrhea
Presence or absence of vomiting, nausea, and abdominal distention
Frequency of antiflatulent usage
Key secondary outcomes
Nutritional parameters (blood albumin, total blood protein, blood trans-thyretin, and body weight)
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The HINE E-gel is given via a naso-gastric tube (12 Fr) by the gravity administration for a week. The daily dose calculated by the Harris-Benedict equation is divided into three administrations which are given morning, noon, and evening.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who are 20 years or older at the date of informed consent
2)Patients who receive the transnasal nutrition with the catheter inserted into the stomach
3)Patients who are able to provide a voluntary consent after receiving the sufficient verbal or written explanation for participation in the study
Key exclusion criteria
1)Patients who might have an allergy to the study product or other food
2)Patients who take gastric acid secretion inhibitor
3)Patients who might not be able to participate in the study because of complications such as hepatic failure, kidney failure, and cardiac disease
4)Female patients who are pregnant, lactating, or potentially pregnant
5)Patients who are deemed unsuitable for inclusion in the study for any other reason by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Goshi |
Organization
Joetsu general hospital
Division name
gastrointestinal medicine
Zip code
Address
616, Daidofukuda, Joetsu-shi, Niigata, Japan
TEL
025-524-3000
goshi@joetsu-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Goshi |
Organization
Joetsu general hospital
Division name
gastrointestinal medicine
Zip code
Address
616, Daidofukuda, Joetsu-shi, Niigata, Japan
TEL
025-524-3000
Homepage URL
goshi@joetsu-hp.jp
Sponsor or person
Institute
Joetsu general 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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 15 | 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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 02 | Day |
Last modified on
| 2015 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015856
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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