UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051260 |
|---|---|
| Receipt number | R000058391 |
| Scientific Title | A placebo-controlled, double-blind, randomized, comparative superiority trial concerning subjective physical symptoms effected by taking lactic acid bacteria in healthy adults. |
| Date of disclosure of the study information | 2023/07/14 |
| Last modified on | 2024/05/21 14:29:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A placebo-controlled, double-blind, randomized, comparative superiority trial concerning subjective physical symptoms effected by taking lactic acid bacteria in healthy adults.
Acronym
A placebo-controlled, double-blind, randomized, comparative superiority trial concerning subjective physical symptoms effected by taking lactic acid bacteria in healthy adults.
Scientific Title
A placebo-controlled, double-blind, randomized, comparative superiority trial concerning subjective physical symptoms effected by taking lactic acid bacteria in healthy adults.
Scientific Title:Acronym
A placebo-controlled, double-blind, randomized, comparative superiority trial concerning subjective physical symptoms effected by taking lactic acid bacteria in healthy adults.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of taking lactic acid bacteria on relief of subjective symptoms related to physical condition in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective symptoms related to physical condition
Key secondary outcomes
Immunological functions
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
In principal take one pack of the test food per day for 16 weeks.
Interventions/Control_2
In principal take one pack of the placebo food per day for 16 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Aged between 18 and less than 65 years old at the date of the consent obtained.
2. Those who have no problems operating PCs and smartphones.
Key exclusion criteria
1. Those who are undergoing treatment for malignant tumor, respiratory disease, liver, kidney, heart, lung, digestive system, blood, endocrine system, metabolic system, etc., or those who have a serious history of these.
2. Those who have or have a history of drug allergies or serious food allergies.
3. Those who are pregnant or breastfeeding, or willing to be pregnant during the trial period.
4. Those who have autoimmune diseases.
5. Alcohol drinking over 40g/day (nearly equal to 2 medium-sized beer bottles) more than 3 days per a week.
6. Those who use drugs that are thought to affect immune function including antiallergic drugs and antibiotics, or who regularly use foods containing specific bifidobacteria, lactic acid bacteria, etc. However, those who can stop after obtaining consent can participate.
7. Those who have participated in other clinical trials within 4 weeks before the date of the consent obtained, or those who plan to participate during the trial period.
8. Those who have collected 400 mL or more of blood within 4 weeks before the consent obtained, or 200 mL or more of blood was collected before the date of pre-intake examination after the consent obtained.
9. Those who have been vaccinated against infectious diseases such as influenza and novel coronavirus within 4 weeks before the day of the pre-ingestion inspection.
10. Those who are judged by the investigator to be unsuitable as a study participant based on the results of study participant background, physical findings, medical examination, physical examination, clinical examination, etc.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Nakamura |
Organization
Higashi Koganei Sakura Clinic
Division name
Chairman
Zip code
184-0011
Address
4-37-26,Higashicho,Koganei-shi,Tokyo,Japan
TEL
042-382-3081
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
03-6704-5968
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
MORINAGA MILK INDUSTRY 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
0367045968
jimukyoku@imeqrd.co.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 | 07 | Month | 14 | 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
| 2023 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058391
