UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Lactobacillus brevis KB290 on bowel movement and on microbiota in subjects with a tendetendency toward constipation: a randomized, double-blind, placebo-controlled, parallel-group trial.
Title of the study (Brief title)	Effect of Lactobacillus brevis KB290 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 evaluate the effect of intervention with Lactobacillus brevis KB290 on bowel movement in subjects with a tendency of constipation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency and days of defecation per week or 2 weeks will be measured. The changes will be compared within each group and between the treatment groups.
Key secondary outcomes	Amount of defecation, Bristol Stool Form Scale, stool color and smell, feeling after defecation will be measured. Also, variety and ratio of bacteria in stool (intestinal microbiota) will be measured. The changes will be compared within each group and between the treatment groups.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	A capsule containing Lactobacillus brevis KB290 per day for 2 weeks.
Interventions/Control_2	A placebo capsule (not containing Lactobacillusu brevis KB290) per day for 2 weeks.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	People whose defecation frequency is no fewer than 3, nor more than 5, and who usually have three meals a day. (Who gave the informed consents in writing after receiving enough explanation of the purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.)
Key exclusion criteria	People who meet any of the following conditions will be excluded. 1) Who regularly use intestinal drugs and laxatives (including strong laxatives). 2) Who can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relieve constipation (including Food for Specified Health Uses (FOSHU)) and/or containing a large amount of sugar alcohol during this study. 3) Who habitually consume higher amount of alcohol (more than 1000 mL in terms of beer per day). 4) Who use medicine such as antibiotics that affect digestion and absorption. 5) Who have allergic to food. 6) Who is pregnant or willing to be pregnant or breast-feeding during this study. 7) Who are participated in other clinical trials that intake/apply any of food, drug, and cosmetics, or willing to be that. 8) Who have serious diseases requiring an urgent treatment, or who accept severe complication. 9) Who has a medical history of diseases or surgeries affecting digestion, absorption and bowel movement (except for appendicectomy). 10) Who has a current or history of drug dependence and/or alcoholism. 11) Who has ever been diagnosed with Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD). 12) Who has an irregular menstrual cycle, or is undergoing treatment for menopause. 13) Who are judged unsuitable for this study based onsubject questionnaire. 14) Who are judged unsuitable for this study by principal investigator.
Target sample size	130

Research contact person
Name of lead principal investigator	Satoshi Sunabori
Organization	Kagome Co., Ltd.
Division name	Innovation Division
Address	17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL	0287-36-2935
Email	Satoshi_Sunabori@kagome.co.jp

Public contact
Name of contact person	Chinatsu Arakawa
Organization	Kagome Co., Ltd.
Division name	Innovation Division
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	KSO Corporation
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	医療法人社団進興会 セラヴィ新橋クリニック（東京都） （Medical Corporation Shinkou Kai C'est la vie Shinbashi Clinic in Tokyo）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 21 Day
Anticipated trial start date	2016 Year 02 Month 14 Day
Last follow-up date	2016 Year 04 Month 16 Day
Date of closure to data entry	2016 Year 05 Month 31 Day
Date trial data considered complete	2016 Year 06 Month 10 Day
Date analysis concluded	2016 Year 06 Month 30 Day

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

Management information
Registered date	2016 Year 02 Month 12 Day
Last modified on	2018 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024231