UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049183 |
|---|---|
| Receipt number | R000056020 |
| Scientific Title | A clinical study for evaluating the effects of food containing lactic acid bacteria on common cold symptoms - A randomized, double-blind, placebo-controlled, parallel-group comparative method - |
| Date of disclosure of the study information | 2022/10/12 |
| Last modified on | 2023/09/06 09:13:16 |
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Basic information
Public title
A clinical study for evaluating the effects of food containing lactic acid bacteria on common cold symptoms - 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 common cold symptoms
Scientific Title
A clinical study for evaluating the effects of food containing lactic acid bacteria on common cold symptoms - 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 common cold symptoms
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous intake of food containing lactic acid bacteria on the immune function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A daily physical health questionnaire survey (about local and systemic symptoms associated with the common cold, general symptoms)
Key secondary outcomes
Salivary sIgA (concentration, secretion rate, secretion amount)
NK cell activity
Serum IgA level
Serum IgG level
pDC activity
Body temperature
Comprehensive analysis of intestinal microbiota
POMS 2 Adult Forms
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
The participants take 3 capsules containing the target lactic acid bacteria once a day for 12 weeks.
Interventions/Control_2
The participants take 3 capsules without the target lactic acid bacteria once a day for 12 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 20 -64 years.
2. Participants who tend to catch a cold or get poor physical conditions.
3. Participants who received a sufficient explanation of the purpose and contents of this study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document.
Key exclusion criteria
Participants (who)
1. suffering from, undergoing treatment for, or with a history of serious diseases
2. have chronic diseases and take medication on a daily basis
3. have been diagnosed with dry mouth
4. are unable to abstain from taking supplement, food for specified health use or functional food, or health food that may affect immune function
5. are unable to abstain from taking food that containing lactic acid bacteria, bifidobacterium, oligosaccharides, or viable bacteria during the study
6. consistently drink more than the appropriate amount of alcohol
7. are unable to abstain from alcohol for 2 days prior to the screening test and each test
8. have food allergies
9. take or plan to take medicine for pollen allergy
10. with digestive diseases affecting digestion and absorption and those with a history of digestive surgery (excluding appendicitis)
11. tend to get diarrhea by taking dairy products
12. are pregnant women, women who intend to become pregnant during the research period, and women who are breastfeeding
13. are judged to be inappropriate as research participants based on blood tests in the screening tests
14. have a history or current condition of drug or alcohol dependence
15. are participating in research involving the ingestion of other foods or the use of other medicines or those who have participated in or are willing to participate in other clinical research within one month of obtaining consent
16. are judged to be inappropriate as research participants by the principal investigator
17. smoke 21 or more cigarettes a day
18. plan to receive the influenza vaccine from 3 weeks before ingestion to the end of the ingestion period
19. plan to receive the COVID-19 vaccine during the ingestion period
20. work on night shift
21. plan to travel abroad during the study
22. has donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining consent, or those who have donated blood components
Target sample size
200
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
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, 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
Shibaura Omodaka Building 7F, 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
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, 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
| 2022 | Year | 10 | Month | 12 | 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 | 09 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 16 | 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 | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056020
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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