UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032387 |
|---|---|
| Receipt number | 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 | 2021/04/27 10:45:58 |
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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 | Tatsuya |
| Middle name | |
| Last name | Tanaka |
Organization
Imari Arita Kyoritsu Hospital
Division name
Neurosurgery
Zip code
849-4141
Address
860 Ninose kou, Arita, Saga, 849-4193, Japan
TEL
0955-46-2121
s96047@hotmail.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Tanaka |
Organization
Imari Arita Kyoritsu Hospital
Division name
Neurosurgery
Zip code
849-4141
Address
860 Ninose kou, Arita, Saga, 849-4193, Japan
TEL
0955-46-2121
Homepage URL
s96047@hotmail.com
Sponsor or person
Institute
Imari Arita Kyoritsu Hospital
Institute
Department
Personal name
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
Meiji Institutional Review Board
Address
Nanakuni, Hachioji, Tokyo, 192-0919, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.com
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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
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
| 2021 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036936
