UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024691 |
|---|---|
| Receipt number | R000028406 |
| Scientific Title | Effect of Lactobacillus brevis KB290 on bowel movement and on intestinal environment in subjects with a tendency toward constipation: a randomized, double-blind, placebo-controlled, cross-over trial. |
| Date of disclosure of the study information | 2016/11/05 |
| Last modified on | 2018/08/16 10:34:46 |
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Basic information
Public title
Effect of Lactobacillus brevis KB290 on bowel movement and on intestinal environment in subjects with a tendency toward constipation: a randomized, double-blind, placebo-controlled, cross-over trial.
Acronym
Effect of Lactobacillus brevis KB290 on bowel movement and intestinal environment.
Scientific Title
Effect of Lactobacillus brevis KB290 on bowel movement and on intestinal environment in subjects with a tendency toward constipation: a randomized, double-blind, placebo-controlled, cross-over trial.
Scientific Title:Acronym
Effect of Lactobacillus brevis KB290 on bowel movement and intestinal environment.
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. The value and changes after intervention treatment will be measured, and compared between each test drinks.
Key secondary outcomes
Amount of defecation, Bristol Stool Form Scale, stool color and smell, feeling after defecation will be measured. Also, Bifidobacterium occupancy and other variety and ratio of bacteria in stool (intestinal microbiota), fecal organic acid concentration will be measured. The changes will be compared between each test drinks.
Base
Study type
Interventional
Study design
Basic design
Cross-over
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 test drink containing Lactobacillus brevis KB290 per day for 3 weeks.
Interventions/Control_2
A placebo drink (not containing Lactobacillus brevis KB290) per day for 3 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
1) People whose defecation frequency is no fewer than 2, nor more than 5.
2) Who usually have three meals a day.
3) Who has lower Bifidobacterium occupancy in stool.
4) 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 and enema).
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 on subject questionnaire.
14) Who are judged unsuitable for this study by principal investigator.
Target sample size
66
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
Kagome Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
KSO Corporation
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
一般財団法人船員保険会 品川シーズンテラス健診クリニック（東京都）
（Shinagawa Season Terrace Health Care Clinic in Tokyo）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 05 | 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
| 2016 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 17 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 18 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 21 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 02 | Day |
Last modified on
| 2018 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028406
