UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059573 |
|---|---|
| Receipt number | R000068137 |
| Scientific Title | Research on gut biomarkers through study food in subjects who are aware they are prone to catching colds |
| Date of disclosure of the study information | 2025/11/04 |
| Last modified on | 2025/10/28 21:09:12 |
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Basic information
Public title
Research on gut biomarkers through study food in subjects who are aware they are prone to catching colds
Acronym
Research on gut biomarkers through study food in subjects who are aware they are prone to catching colds
Scientific Title
Research on gut biomarkers through study food in subjects who are aware they are prone to catching colds
Scientific Title:Acronym
Research on gut biomarkers through study food in subjects who are aware they are prone to catching colds
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects on fecal s-IgA and safety during 12 weeks of continuous intake of the study food, using a placebo as a control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fecal s-IgA
Key secondary outcomes
bowel movement record (number, stool characteristics (form, color, odor, feeling after defecation))
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
Consecutive intake of study food one tablet once daily for 12 weeks
Interventions/Control_2
Consecutive intake of placebo one tablet once daily 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 64 years of age
(2) Subjects who are aware they are prone to catching colds
(3) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study
Key exclusion criteria
(1) Subjects who have a disease requiring constant medication, with a disease under treatment, or with a history of a serious disease requiring medication therapy
(2) Subjects suffering from gastrointestinal disorders that affect digestion absorption, defecation or who have a history of previous illnesses or surgeries
(3) Subjects with chronic and severe constipation or tendency toward diarrhea/loose stools, or who exhibiting distinct digestive symptoms from specific foods like lactose intolerance or gluten-related disorders
(4) Subjects with pre-existing conditions that require diet therapy under the guidance of a doctor
(5) Subjects who have atopic dermatitis, bronchial asthma, and chronic bronchitis
(6) Subjects who may require medication or treatment for hay fever or allergic rhinitis, or may cause difficulties in daily life
(7) Subjects who are taking medicines, health foods that may affect immune function or bowel movements at least 3 times a week, or plan to take
(8) Subjects who have reported allergies to food or medicines, or individuals at risk of developing allergies
(9) Subjects who habitually consume foods rich lactic acid bacteria, lactic acid bacteria preparations, or foods rich acetic acid bacteria at least 3 times per week
(10) Subjects who vaccinated within 4 weeks, or hope for vaccination
(11) Subjects planning to travel abroad
(12) Subjects determined to have excessive drinking or smoking habits
(13) Subjects who are becoming pregnant and lactating or intend to become pregnant
(14) Subjects engaged in shift work involving day and night rotations or physically demanding labor such as heavy lifting
(15) Subjects who habitually engage in strenuous exercise such as marathon running
(16) Subjects who participated in another clinical trial within 1 month, or plan to participate
(17) Subjects whose screening values show significant deviation from reference range
(18) Subjects who are judged as unsuitable for the study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Takeda |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7 Sengawacho, Chofu-shi, Tokyo
TEL
03-5384-7759
yumi_takeda@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Yamamoto |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
6-29 Shinogawamachi, Shinjuku-ku, Tokyo
TEL
070-3023-8214
Homepage URL
yamamoto.keiji799@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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
epmd_fd-erb@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
メディカルステーションクリニック (Medical station clinic) (東京都)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068137
