UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of nutritional route (nasal or gastrostoma) and nutritional form (liquid or semi solid) in stroke patients with tube feeding.
Acronym	Comparison of nutritional route (nasal or gastrostoma) and nutritional form (liquid or semi solid) in stroke patients with tube feeding.
Scientific Title	Comparison of nutritional route (nasal or gastrostoma) and nutritional form (liquid or semi solid) in stroke patients with tube feeding.
Scientific Title:Acronym	Comparison of nutritional route (nasal or gastrostoma) and nutritional form (liquid or semi solid) in stroke patients with tube feeding.
Region	Japan

Condition
Condition	stoke patients with tube feeding, slated for gastrostomy
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the pain of patients on tube feeding with different nutritional routes (nasal or gastrostoma) and forms (liquid or semi-solid). To compare the time for tube feeding and the occurrence of vomiting and diarrhea with different nutritional forms (liquid or semi solid)
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The pain of patients on tube feeding, comparing with nutritional route (nasal or gastrostoma) and form (liquid or semi-solid). The time for tube feeding, comparing with nutritional forms (liquid or semi solid).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Feeding via nasal tube with liquid diet at least for 7 days. After the PEG, feeding via gastrostomic tube with liquid diet for 7 days, then with semi-solid diet for 7 days.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients under tube feeding with liquid diet and depend on it for 70% or more. 2. Patients slated for PEG. 3. Patients over 65 years-old 4. Patients who have given written informed consent by themselves or their representative.
Key exclusion criteria	1. Patients under intermittent tube feeding. 2. Patients who need special diets, because of diabetes, renal dysfunction and so on. 3. Patients who have few gastrointestinal tract function by inflammatory bowel disease or short bowels syndrome. 4. Other conditions not suitable for this study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hidekazu Sugawara
Organization	Kaifukuki Rehabilitaion Ward Association
Division name	Board member
Zip code
Address	Kyosai building 202, 3-52-6 Hon-machi, Shibuya-ku, Tokyo, Japan
TEL	03-5365-8529
Email	kaifukuki@rehabili.jp

Public contact
Name of contact person	1st name Middle name Last name Hidekazu Sugawara
Organization	Kaifukuki Rehabilitaion Ward Association
Division name	Board member
Zip code
Address	Kyosai building 202, 3-52-6 Hon-machi, Shibuya-ku, Tokyo, Japan
TEL	03-5365-8529
Homepage URL
Email	kaifukuki@rehabili.jp

Sponsor
Institute	Kaifukuki Rehabilitaion Ward Association
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research from the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding 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	西広島リハビリテーション病院（広島県）/ Nishihiroshima Rehabilitation Hospital (Hiroshima) 昭和大学藤が丘リハビリテーション病院（神奈川）/ Showa University Fujigaoka rehabilitation Hospital (Kanagawa) 藤田保健衛生大学七栗サナトリウム（三重）/ Fujita Health University Nanakuri Sanatorium (Mie) 川崎医科大附属病院（岡山県）/ Kawasaki Medical School Hospital(Okayama)

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 10 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	Completed
Date of protocol fixation	2013 Year 11 Month 07 Day
Date of IRB	2014 Year 01 Month 08 Day
Anticipated trial start date	2014 Year 03 Month 08 Day
Last follow-up date	2014 Year 12 Month 31 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 05 Month 31 Day
Date analysis concluded	2015 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2013 Year 12 Month 09 Day
Last modified on	2021 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014666