UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015959 |
|---|---|
| Receipt number | R000018530 |
| Scientific Title | A study of clinical usefulness and safety of enteral nutrition containing pectin. |
| Date of disclosure of the study information | 2015/02/12 |
| Last modified on | 2017/06/19 11:03:22 |
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Basic information
Public title
A study of clinical usefulness and safety of enteral nutrition containing pectin.
Acronym
A study of clinical usefulness and safety of enteral nutrition containing pectin.
Scientific Title
A study of clinical usefulness and safety of enteral nutrition containing pectin.
Scientific Title:Acronym
A study of clinical usefulness and safety of enteral nutrition containing pectin.
Region
| Japan |
Condition
Condition
Patients on nasoeal feeding
Classification by specialty
| Medicine in general | Surgery in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A study of clinical usefulness and safety of enteral nutrition containing pectin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of nutrition mamagement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
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
| Food | Other |
Interventions/Control_1
Patients are taken enteral nutrition containing pectin for 7 days
Interventions/Control_2
Patients are taken nomal enteral nutrition for 7 days
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 on tube feeding, not oral intake
2.Patients on NG tube
3.Patients taking on tube feeding only
4.Patients taken more than half of the planned adminitration amount of energy the day before
5.Patients taken enteral nutrition for a week or more after the start of this study
6.Patients informed consent
Key exclusion criteria
1.Patients with diarrhea the day before
2.Patients treated with the disable drug and REF-P1
3.Patients undergone with total or subtotal gastrectomy
4.Patients treated with the chemotherapy
5.Patients with the ileus
6.Patients with electrolyte imbalance
7.Patients with severe liver dysfunction or severe kidney dysfunction
8.Patiens with glucose metabolism disorder such as diabetes or inborn error of amino acid metabolism
9.Patients with infectious enteritis
10.Patients with other conditions not suitable for this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Maruyama |
Organization
Japan Society for Parenteral and Enteral Nutiroin
Division name
Clinical Nutrition Working Committee
Zip code
Address
Shiba-Daimon116bdlg 3F-B 1-16-3 Shiba-Daimon Minato-ku Tokyo Japan
TEL
03-5777-2314
jspen2@jspen.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Maruyama |
Organization
Japan Society for Parenteral and Enteral Nutiroin
Division name
Clinical Nutrition Working Committee
Zip code
Address
Shiba-Daimon116bdlg 3F-B 1-16-3 Shiba-Daimon Minato-ku Tokyo Japan
TEL
03-5777-2314
Homepage URL
jspen2@jspen.jp
Sponsor or person
Institute
Japan Society for Parenteral and Enteral Nutiroin
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc
Organization
Division
Category of Funding Organization
Profit organization
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 | 02 | Month | 12 | 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
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 10 | 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
| 2014 | Year | 12 | Month | 15 | Day |
Last modified on
| 2017 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018530
