UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034038 |
|---|---|
| Receipt number | 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 | 2020/09/09 11:21:34 |
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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
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
Chinatsu_Arakawa@kagome.co.jp
Sponsor or person
Institute
Kagome Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038736
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