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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032387
Receipt No. R000036936
Scientific Title Beneficial effects of formula containing fermented milk products in persons with tube feeding.
Date of disclosure of the study information 2019/03/01
Last modified on 2018/04/26

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Basic information
Public title Beneficial effects of formula containing fermented milk products in persons with tube feeding.
Acronym Beneficial effects of formula containing fermented milk products in persons with tube feeding.
Scientific Title Beneficial effects of formula containing fermented milk products in persons with tube feeding.
Scientific Title:Acronym Beneficial effects of formula containing fermented milk products in persons with tube feeding.
Region
Japan

Condition
Condition Persons with cerebrovascular disease
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of enteral formula containing fermented milk products on gastroesophageal reflux in persons with tube feeding.
Basic objectives2 Others
Basic objectives -Others Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes There is no primary outcome because this study is exploratory.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Tube feeding with enteral formula containing fermented milk products and assess the presence of carbohydrate in expectoration.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Individuals who provided written informed consent by legally acceptable guardian.
If possible, informed assent will be obtained.
Adult inpatients with cerebrovascular disease.
Patients treated with gastric secretion inhibitor.
Patients on NG tube presenting with gastroesophageal reflux by neutral pH enteral formula.
Key exclusion criteria Allergy to milk or soy.
Past history of aspiration pneumonia.
Nasoenteric tube is placed in the jejunum, past the ligament of Treitz.
Individuals who refuse informed assent.
Individuals who judged inappropriate for the study by the principal.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Tanaka
Organization Imari Arita Kyoritsu Hospital
Division name Neurosurgery
Zip code
Address 860 Ninose kou, Arita, Saga, 849-4193, Japan
TEL 0955-46-2121
Email s96047@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Tanaka
Organization Imari Arita Kyoritsu Hospital
Division name Neurosurgery
Zip code
Address 860 Ninose kou, Arita, Saga, 849-4193, Japan
TEL 0955-46-2121
Homepage URL
Email s96047@hotmail.com

Sponsor
Institute Imari Arita Kyoritsu Hospital
Institute
Department

Funding Source
Organization Meiji Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Meiji Co., Ltd.
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 伊万里有田共立病院/Imari Arita Kyoritsu Hospital

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 26 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
2018 Year 04 Month 26 Day
Last modified on
2018 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036936

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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