UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012532
Receipt number R000014666
Scientific Title Comparison of nutritional route (nasal or gastrostoma) and nutritional form (liquid or semi solid) in stroke patients with tube feeding.
Date of disclosure of the study information 2013/12/10
Last modified on 2021/06/15 16:19:59

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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 or person

Institute

Kaifukuki Rehabilitaion Ward Association

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014666


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name