UMIN-CTR Clinical Trial

Basic information
Public title	A study for evaluating the effect of intake of food containing lactic acid bacteria on QOL. An open trial.
Acronym	A study for evaluating the effect of intake of food containing lactic acid bacteria on QOL.
Scientific Title	A study for evaluating the effect of intake of food containing lactic acid bacteria on QOL. An open trial.
Scientific Title:Acronym	A study for evaluating the effect of intake of food containing lactic acid bacteria on QOL.
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of intake of food containing lactic acid bacteria on QOL.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire of QOL by SF-36
Key secondary outcomes	Defecation frequency, fecal shape, analysis of gut microbiota

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	Prevention
Type of intervention	Food
Interventions/Control_1	Food containing lactic acid bacteria (2 weeks intake)
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Males and Females over 50 years old living in Daigo Town, Ibaraki (2) Subjects giving written informed consent
Key exclusion criteria	(1) Individuals presenting known food allergy (2) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (3) Individuals who are under treatment or have a history of drug/alcohol dependence (4) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics (5) Individuals who are judged as unsuitable for the study by the investigator
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Keishiro Middle name Last name Yoshida
Organization	Lotte Co., Ltd.
Division name	Central Laboratory , Food material development section
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0187
Email	yoshida_keishirou@lotte.co.jp

Public contact
Name of contact person	1st name Keishiro Middle name Last name Yoshida
Organization	Lotte Co., Ltd.
Division name	Central Laboratory , Food material development section
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0187
Homepage URL
Email	yoshida_keishirou@lotte.co.jp

Sponsor
Institute	Lotte Co., Ltd.
Institute
Department

Funding Source
Organization	Lotte Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shiba Palace Clinic institutional review board
Address	6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel	03-5408-1599
Email	jimukyoku@mail.souken-r.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

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 26 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 08 Month 30 Day
Date of IRB	2018 Year 08 Month 30 Day
Anticipated trial start date	2018 Year 09 Month 27 Day
Last follow-up date	2018 Year 10 Month 18 Day
Date of closure to data entry	2018 Year 11 Month 15 Day
Date trial data considered complete	2018 Year 11 Month 22 Day
Date analysis concluded	2018 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date	2018 Year 09 Month 20 Day
Last modified on	2020 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039003