UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of clinical usefulness and safety of enteral nutrition containing pectin.
Title of the study (Brief title)	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	Michio Maruyama
Organization	Japan Society for Parenteral and Enteral Nutiroin
Division name	Clinical Nutrition Working Committee
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	Michio Maruyama
Organization	Japan Society for Parenteral and Enteral Nutiroin
Division name	Clinical Nutrition Working Committee
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000018530