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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034038
Receipt No. R000038736
Scientific Title Effect of Lactobacillus brevis KB290(heat-killed) on bowel movement and on microbiota in subjects with a tendency toward constipation.
Date of disclosure of the study information 2018/10/24
Last modified on 2018/09/05

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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
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
2018 Year 09 Month 05 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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