UMIN-CTR Clinical Trial

Basic information
Public title	Effects of formula containing fermented milk products on physical condition in enterally fed patients
Acronym	Effects of formula containing fermented milk products on physical condition in enterally fed patients
Scientific Title	Effects of formula containing fermented milk products on physical condition in enterally fed patients
Scientific Title:Acronym	Effects of formula containing fermented milk products on physical condition in enterally fed patients
Region	Japan

Condition
Condition	diarrhea, constipation
Classification by specialty	Medicine in general Gastroenterology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of 56 days nutritional management by enteral formula containing fermented milk products on defecation and nutritional status in enterally fed patients dosed with laxative
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	defecation
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	56 days nutritional management by enteral formula containing fermented milk products
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Individuals who provided written informed consent by legally acceptable guardian. Because the subjects are unconscious, informed assent will not be obtained. 2.Enterally fed patients who dosed with laxative
Key exclusion criteria	1.Individualds who already take enteral formula containing fermented milk products 2.Individualds with liver dysfunction 3.Allergy to milk or soy 4.Individualds who judged by the principal investigator or sub investigator to be inappropriate as a subject
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Tsukuru Middle name Last name Hashimoto
Organization	Sonoda hospital
Division name	director
Zip code	661-0953
Address	2-48-7,Higashionodacho,Amagasaki-shi,hyogo-ken,661-0953,japan
TEL	06-6491-9521
Email	hasimoto@sonodamedic.or.jp

Public contact
Name of contact person	1st name Tsukuru Middle name Last name Hashimoto
Organization	sonoda hospital
Division name	director
Zip code	661-0953
Address	2-48-7,Higashionodacho,Amagasaki-shi,hyogo-ken,661-0953,japan
TEL	06-6491-9521
Homepage URL
Email	hasimoto@sonodamedic.or.jp

Sponsor
Institute	sonoda 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
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Meiji Institutional Review Board
Address	Nanakuni, Hachioji-shi, 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	園田病院（兵庫県）／sonoda hospital

Other administrative information
Date of disclosure of the study information	2020 Year 04 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	10
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	2020 Year 02 Month 25 Day
Date of IRB	2020 Year 02 Month 20 Day
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2021 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	2020 Year 03 Month 09 Day
Last modified on	2022 Year 01 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045297