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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015959
Receipt No. 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

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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
Email 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
Email jspen2@jspen.jp

Sponsor
Institute Japan Society for Parenteral and Enteral Nutiroin
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018530

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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