UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048914 |
|---|---|
| Receipt number | R000055734 |
| Scientific Title | A clinical study for evaluating the effects of food containing lactic acid bacteria on intestinal environment. - A randomized, double-blind, placebo-controlled, parallel-group comparative method - |
| Date of disclosure of the study information | 2023/12/04 |
| Last modified on | 2024/08/29 10:35:33 |
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Basic information
Public title
A clinical study for evaluating the effects of food containing lactic acid bacteria on intestinal environment.
- A randomized, double-blind, placebo-controlled, parallel-group comparative method -
Acronym
A clinical study for evaluating the effects of food containing lactic acid bacteria on intestinal environment.
Scientific Title
A clinical study for evaluating the effects of food containing lactic acid bacteria on intestinal environment.
- A randomized, double-blind, placebo-controlled, parallel-group comparative method -
Scientific Title:Acronym
A clinical study for evaluating the effects of food containing lactic acid bacteria on intestinal environment.
Region
| Japan |
Condition
Condition
Subjects with a tendency for constipation
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of food containing lactic acid bacteria 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 Lactobacilli in feces, butyric acid content in feces
Key secondary outcomes
Defecation survey, analysis of gut microbiota, organic acids content in feces, bile acids content in feces, pH and water content in feces, putrefactive product content in feces, ammonia content in feces, PAC-QOL Japanese version
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingest the capsules containing the target lactic acid bacteria every day for 4 weeks.
Interventions/Control_2
Ingest the capsules without the target lactic acid bacteria every day for 4 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese males and females aged from 20 and 64 years old
2. Subjects with bowel movements between 3 to 5 times a weeks at the point of screening examination
3. Subjects having an ability to understand study purpose and detail with voluntary written informed consent
Key exclusion criteria
Subjects(who)
1. suffering from, undergoing treatment for, or with a history of serious diseases
2. have a chronic diseases and take medication on a daily basis
3. consume medication that potentially affect the intestinal environment on a daily basis
4. consume foods that potentially affect the intestinal environment more than 5 times a week
5. are unable to abstain from taking foods that potentially affect the intestinal environment.
6. have taken antibiotics within 2 weeks before the point of screening examination
7. perform high-intensity exercise intended for muscle building more than 3 times a week
8. smoke 21 or more cigarettes a day
9. have a history or current condition of drug or alcohol dependence
10. consistently drink more than the appropriate amount of alcohol
11. are planning major changes in their environment during the study period
12. with digestive diseases affecting digestion and absorption and with a history of digestive surgery
13. have food/ medication allergies
14. are judged to be inappropriate as subjects by background survey
15. are pregnant or breast-feeding, or have the will of pregnancy during the study period
16. are participating or are planning to participate in other clinical studies, and had participated within 1 month of obtaining informed consent
17. are judged to be inappropriate as subjects by screening examination
18. plan to travel abroad, including overseas travel, during the study period
19. are judged as inappropriate by investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
#201 Kyodo Bldg. 13-4 Nihonbashi Kodenma-cho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
7F Shibaura Omodaka Bldg. 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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
Ethical Committee of Nihonbashi Cardiology Clinic
Address
#201 Kyodo Bldg. 13-4 Nihonbashi Kodenma-cho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.jp
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
| 2023 | Year | 12 | Month | 04 | 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
| 2022 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 12 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055734
