Healthy adult
Conditions
Interventions
Consecutive intake of study food one tablet once daily for 12 weeks
Consecutive intake of placebo one tablet once daily for 12 weeks
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fecal s-IgA | — |
Secondary
| Measure | Time frame |
|---|---|
| bowel movement record (number, stool characteristics (form, color, odor, feeling after defecation)) | — |
Countries
Japan
Contacts
Public ContactKeiji Yamamoto
EP Mediate Co., Ltd. Development Department Trial Planning Section
Outcome results
None listed