UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052242 |
|---|---|
| Receipt number | R000059635 |
| Scientific Title | A study for evaluating the effect of a food containing lactic acid bacteria on immune modulation function |
| Date of disclosure of the study information | 2023/09/19 |
| Last modified on | 2024/08/29 17:22:30 |
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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
Acronym
A study for evaluating the effect of a food containing lactic acid bacteria on immune modulation function
Scientific Title
A study for evaluating the effect of a food containing lactic acid bacteria on immune modulation function
Scientific Title:Acronym
A study for evaluating the effect of a food containing lactic acid bacteria on immune modulation function
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| 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 QOL for the common cold symptom and immunity biomarker for 8 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Cumulative score with cold symptoms
(2)Cumulative days with cold symptoms
Key secondary outcomes
(1)average score with cold symptoms
(2)pDC activity (MFI of CD86, HLA-DR, CD40 and CD80) in the peripheral blood
(3)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 product for 8 consecutive weeks
Interventions/Control_2
Ingestion of the placebo for 8 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 will be selected cold like symptoms during pre-treatment observation period and result of a preliminary examination
(4)Subjects who can agree in writing to participate in the study
Key exclusion criteria
(1)Subjects who have disease requiring medication, and treatment except dry eye and cavity protection, or have a history of serious treatment
(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 atopic dermatitis, bronchial asthma, and chronic bronchitis
(4)Subjects who take antiallergic drugs
(5)Subjects who cannot restrict the use of medicines or health foods that may influence this study after informed consent
(6)Subjects who vaccinated influenza or the corona vaccine within four weeks on preliminary examination and hope for vaccination during an intake period
(7)Heavy drinkers of alcohol
(8)Heavy excessive smokers
(9)Subjects who are planning to travel abroad during the study period, or who are planning of overseas business trip
(10)Subjects who are becoming pregnant and lactating or intend to become pregnant
(11)Night and day shift worker
(12)Subjects who have participated in other clinical studies within one month before giving consent or plan to participate during the present study period
(13)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(14)Subjects who are judged as unsuitable for the study based on the results of clinical examination or cardiopulmonary abnormality in the past
(15)Subjects having possibilities for emerging allergy relates to the study
(16)Subjects who are judges as unsuitable for the study bases on the result of clinical and physical examination on preliminary examination
(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 lab
Zip code
348-8549
Address
272, Tsutsumine, Kamimurakimi, Hanyu-shi, Saitama
TEL
048-565-4686
shuichi.segawa@nissin.com
Public contact
Name of contact person
| 1st name | Tamaki |
| Middle name | |
| Last name | Furuhata |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department, Trial Planning Section 1
Zip code
162-0821
Address
AK Building, 1-8, Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-3023-8207
Homepage URL
furuhata.tamaki686@eps.co.jp
Sponsor or person
Institute
EP Mediate 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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.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 | 09 | Month | 19 | 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
200
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 | 08 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 09 | Month | 19 | 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=R000059635
