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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024691
Receipt No. 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

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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
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 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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028406

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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