UMIN-CTR Clinical Trial

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
Email	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
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	Meiji Institutional Review Board
Address	Nanakuni, Hachioji, Tokyo, 192-0919, Japan
Tel	042-632-5900
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036936