UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028539 |
|---|---|
| Receipt number | 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 17:59:00 |
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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
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
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032654
