UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Lactobacillus brevis KB290(heat-killed) on bowel movement and on microbiota in subjects with a tendency toward constipation.
Acronym	Effect of Lactobacillus brevis KB290(heat-killed) on bowel movement and microbiota.
Scientific Title	Effect of Lactobacillus brevis KB290(heat-killed) on bowel movement and on microbiota in subjects with a tendency toward constipation.
Scientific Title:Acronym	Effect of Lactobacillus brevis KB290(heat-killed) on bowel movement and microbiota.
Region	Japan

Condition
Condition	people tend to be constipated
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate effect of Lactobacillus brevis KB290(heat-killed) on bowel movement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency and days of defecation. The value and changes after intervention treatment will be compared between each test beverages.
Key secondary outcomes	Amount of defecation, Bristol Stool Form Scale, stool color and smell, feeling after defecation, fecal microbiota. The value and changes after intervention treatment will be compared between each test beverages.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	A placebo drink (not containing Lactobacillus brevis KB290) per day for 2 weeks.
Interventions/Control_2	A test drink containing low volume of heat killed Lactobacillus brevis KB290 per day for 2 weeks.
Interventions/Control_3	A test drink containing medium volume of heat killed Lactobacillus brevis KB290 per day for 2 weeks.
Interventions/Control_4	A test drink containing high volume of heat killed Lactobacillus brevis KB290 per day for 2 weeks.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Who tends to be constipated(defecation frequency is 2-5 days per a week). 2) Who usually has three meals a day.
Key exclusion criteria	1)Who regularly consumes some food containing viable bacteria such as yorgurt, fermented beverage with lactic acid bacteria, natto, kimchi, and tsukemono (excluding those who can stop the consumption during this study). 2)Who cannot stop to use/intake a drug (e.g. intestinal drugs and laxatives), health foods, Food for Specified Health Uses, Foods with Function Claims, health food, dietary supplements and other supplements, and/or foods enhanced with oligosaccharide or dietary fiber. 3)Who has bowel movement illness and go to a hospital regularly, and on medication, or using over-the-counter laxatives. 4)Who has receive medical treatments for gastrointestinal diseases that affect regulation of intestinal function, or a history of those (except for appendicectomy). 5)Who has such diseases as irritable bowel syndrome or ulcerative colitis that significantly affect bowel movements, or a history of those. 6)Who has such diseases as diabetes, liver diseases, kidney diseases, heart diseases, or a history of those. 7)Who is on exercise or diet therapy under the direction of a physician. 8)Who has diseases requiring continuous medication. 9)Who has a history of serious disease requiring medication. 10)Who has allergic to drug or food. 11)Who are judged as unsuitable for this study based on subject questionnaire. 12) Who is judged as unsuitable for this study based on the results of physical and clinical examination on screening test. 13)Who is pregnant or breast-feeding or willing to be pregnant during this study. 14)Who has a mental disorders (e.g. depression) or a history of that. 15)Who is employed on night or on shift work. 16)Who has a current or history of drug dependence or drug abuse. 17)Who has participated in other clinical study within the last three months prior to the date of consent to participating on this study, or willing to be that. 18)Who is judged unsuitable for this study by principal investigator.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigenori Suzuki
Organization	Kagome Co., Ltd.
Division name	Innovation Division
Zip code
Address	17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL	0287-36-2935
Email	Shigenori_Suzuki@kagome.co.jp

Public contact
Name of contact person	1st name Middle name Last name Chinatsu Arakawa
Organization	Kagome Co., Ltd.
Division name	Innovation Division
Zip code
Address	17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL	0287-36-2935
Homepage URL
Email	Chinatsu_Arakawa@kagome.co.jp

Sponsor
Institute	Kagome Co., Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	HUMA R&D
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	医療法人社団桜緑会　日本橋さくらクリニック（東京都） ／Nihonbashi Sakura Clinic

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 24 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	Preinitiation
Date of protocol fixation	2018 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date	2018 Year 10 Month 24 Day
Last follow-up date	2018 Year 12 Month 06 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 09 Month 05 Day
Last modified on	2020 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038736