UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055717 |
|---|---|
| Receipt number | R000063584 |
| Scientific Title | A study for evaluating the effect of a food containing lactic acid bacteria on immune modulation function (including long-term safety) |
| Date of disclosure of the study information | 2024/10/04 |
| Last modified on | 2025/12/05 08:50:11 |
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Basic information
Public title
A study for evaluating the effect of a food containing lactic acid bacteria on immune modulation function (including long-term safety)
Acronym
A study for evaluating the effect of a food containing lactic acid bacteria on immune modulation function (including long-term safety)
Scientific Title
A study for evaluating the effect of a food containing lactic acid bacteria on immune modulation function (including long-term safety)
Scientific Title:Acronym
A study for evaluating the effect of a food containing lactic acid bacteria on immune modulation function (including long-term safety)
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to verify the effect of food containing lactic acid bacteria on cold like symptoms and immune biomarkers for 8 weeks. In addition, the long-term safety for 12 weeks will be confirmed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1] Cumulative days with each item of WURSS-21
[2] Cumulative days with each item of cold like symptoms
Key secondary outcomes
[1] Cumulative score with each item of WURSS-21
[2] Cumulative score with each item of cold like symptoms
[3] pDC activity (MFI of CD86, HLA-DR, CD40 and CD80) in the peripheral blood
[4] The proportion of phylum and family of intestinal bacteria
[5] NK activity
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
Ingestion of the test food for 12 consecutive weeks
Interventions/Control_2
Ingestion of placebo (control food) for 12 consecutive 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[1] Males and females from 18 to 64 years of age
[2] Subject who did have cold like symptoms in winter within 2 years
[3] Subjects who are judged as eligible for the study based on cold like symptoms during pre-treatment observation period and results of the screening test
[4] Subjects who have been fully informed of the purpose and content of the study, and submit the written informed consent form
Key exclusion criteria
[1] Subjects who have disease requiring medication, and treatment except dry eye and cavity protection, or have a history of serious illness required medications
[2] Subjects having the disease past medical history that needed a diet and exercise therapy under the management of the doctor
[3] Subjects who having allergic rhinitis, atopic dermatitis, bronchial asthma, and chronic bronchitis
[4] Subjects who cannot restrict the use of medicines or health foods that may influence this study after informed consent
[5] Subjects who received vaccine shot includes influenza or the corona vaccine within six months before the screening test and hope for vaccination during an intake period
[6] Heavy drinkers of alcohol
[7] Current smokers
[8] Subjects who are planning to travel abroad during the study period, or who are planning of overseas business trip
[9] Night and day shift worker
[10] Subjects who have participated in other clinical studies within one month before giving consent or plan to participate during the present study period
[11] Subjects who are judged as unsuitable for the study based on the results of Wisconsin Upper Respiratory Symptom Survey short versions(WURSS-21)Japanese version
[12] Subjects who are judged as unsuitable for the study based on the results of clinical examination or cardiopulmonary abnormality in the past
[13] Subjects who have allergy
[14] Subjects who are judges as unsuitable for the study based on the result of clinical and physical examination on screening test
[15] Subjects who are becoming pregnant and lactating or intend to become pregnant
[16] Subjects who may be unable to maintain their daily lifestyle
[17] Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Segawa |
Organization
NISSIN YORK CO., LTD.
Division name
Development Laboratories
Zip code
348-8549
Address
272, Tsutsumine, Kamimurakimi, Hanyu-shi, Saitama, 348-8549, Japan
TEL
048-565-4686
shuichi.segawa@nissin.com
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Koizumi |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027, Japan
TEL
03-6777-7789
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
NISSIN YORK 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
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, Japan
Tel
03-3741-0223
food-contact@apoplus.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
医療法人社団 渡辺病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | 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
| 2024 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063584
