UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of continuous intake of fermented milk products on bowel habit in the elderly in a nursing home. How does the result effect facilities administration?
Title of the study (Brief title)	Effect of continuous intake of fermented milk products on bowel habit
Region	Japan

Condition
Condition	inpatient, nursing staff
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objectives of this study are as follows: (1) to evaluate changes in defecation among patients admitted to a psychiatric hospital when fermented milk products are ingested on a regular basis; (2) to evaluate the changes in expenditure owing to (i) the amount of purgatives used for treating disorders related to defecation and (ii) the purchase of fermented milk products required to be added to the normal diet; and (3) to verify whether the sense of burden among the nursing staff who assist patients with defecation is changed.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the amount of purgatives stool frequency ,stool consistency, odor of stool, Change of caregiver burden on nursing staff One week before intervention start, 3 months later, 6 months later, intervention end one month later
Key secondary outcomes	Expendable usage,cost of fermented milk products

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Fermented milk products one a day 6 months
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	A mental hospital inpatient and nursing staff
Key exclusion criteria	Individuals judged by the doctor to be unsuitable.
Target sample size	100

Research contact person
Name of lead principal investigator	Hiromi Ishida
Organization	Kagawa nutrition university
Division name	Administrative dietetics
Address	3- 9-21Chiyoda Sakado Saitama
TEL	049-281-3211
Email	ishida@eiyo.ac.jp

Public contact
Name of contact person	Hiromi Ishida
Organization	Kagawa nutrition university
Division name	Administrative dietetics
Address	3- 9-21Chiyoda Sakado Saitama
TEL	049-281-3211
Homepage URL
Email	ishida@eiyo.ac.jp

Sponsor
Institute	Kagawa nutrition university
Institute
Department

Funding Source
Organization	YAKULT HONSHA CO. LTD. Metropolitan Branch
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 06 Day
Anticipated trial start date	2016 Year 01 Month 25 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 23 Day
Last modified on	2016 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025832