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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028539
Receipt No. R000032654
Scientific Title A study for evaluating the effects of oral intake of food containing lactic acid bacteria on intestinal environment. A placebo-controlled, randomized, double-blind, cross-over trial.
Date of disclosure of the study information 2017/08/04
Last modified on 2018/04/27

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Basic information
Public title A study for evaluating the effects of oral intake of food containing lactic acid bacteria on intestinal environment. A placebo-controlled, randomized, double-blind, cross-over trial.
Acronym A study for evaluating the effects of oral intake of food containing lactic acid bacteria on intestinal environment.
Scientific Title A study for evaluating the effects of oral intake of food containing lactic acid bacteria on intestinal environment. A placebo-controlled, randomized, double-blind, cross-over trial.
Scientific Title:Acronym A study for evaluating the effects of oral intake of food containing lactic acid bacteria on intestinal environment.
Region
Japan

Condition
Condition Subjects with a tendency for constipation
Classification by specialty
Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of food containing lactic acid bacteria(Lactobacillus brevis) on intestinal environment of subjects with a tendency for constipation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of Lactobacillus genus in feces, number of Bifidobacterium genus in feces, acetic acid content in feces
Key secondary outcomes Organic acids content in feces, analysis of gut microbiota, diversity of gut microbiota, metagenomic analysis of functional profile of gut microbiota community, ammonia content in feces, decay product content in feces, pH and water content in feces, questionnaire(Defecation days, defecation frequency, fecal amount fecal shape, fecal color, fecal odor, feeling after defecation)

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Food containing lactic acid bacteria (2 weeks intake) - washout period (2 weeks) - placebo (not containing lactic acid bacteria) (2 weeks intake)
Interventions/Control_2 Placebo (not containing lactic acid bacteria) (2 weeks intake) - washout period (2 weeks) - food containing lactic acid bacteria (2 weeks intake)
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
65 years-old >
Gender Male and Female
Key inclusion criteria (1) Males and females from 20 to 64 years of age
(2) Subjects with a tendency for constipation at three to five times of defecation per week at the point of screening examination(2 weeks)
(3) Subjects giving written informed consent
Key exclusion criteria (1) Individuals taking antiflatulents and/or laxatives (including purgative drug) in common use
(2) Individuals taking health foods in common use, which influence intestinal regulation at the point of screening examination
(3) Individuals taking antibiotics and/or drugs which influence laxatives(including purgative drugs) in common use at the point of screening examination
(4) Individuals who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use and food with function claim, which influence intestinal regulation during the study period
(5) Individuals presenting known food allergy
(6) Individuals taking large amounts of alcohol on a daily basis
(7) Individuals who are suffered from a disease which needs treatment urgently or individuals with severe complications
(8) Individuals with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation
(9) Individuals who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire
(10) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period
(11) Individuals who are under treatment or have a history of drug/alcohol dependence
(12) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics
(13) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Iwama
Organization Nihonbashi Cardiology Clinic
Division name Director
Zip code
Address 13-4 Nihonbashi Kodenma-cho Chuo-ku Tokyo-to
TEL 03-5641-4133
Email yiwama@well-sleep.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Lotte Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://lifescience.co.jp/yk/yk18/ykj1804.html
Number of participants that the trial has enrolled
Results
Jpn Pharmacol Ther 2018 46(4)549-60
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
2017 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 05 Day
Last follow-up date
2017 Year 10 Month 14 Day
Date of closure to data entry
2017 Year 11 Month 14 Day
Date trial data considered complete
2017 Year 11 Month 29 Day
Date analysis concluded
2018 Year 02 Month 21 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 04 Day
Last modified on
2018 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032654

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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