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A study for evaluating the effect of a food containing lactic acid bacteria on immune modulation function

A study for evaluating the effect of a food containing lactic acid bacteria on immune modulation function - A study for evaluating the effect of a food containing lactic acid bacteria on immune modulation function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052242
Enrollment
200
Registered
2023-09-19
Start date
2023-09-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Sponsors

EP Mediate Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
(1)Cumulative score with cold symptoms (2)Cumulative days with cold symptoms

Secondary

MeasureTime frame
(1)average score with cold symptoms (2)pDC activity (MFI of CD86, HLA-DR, CD40 and CD80) in the peripheral blood (3)NK activity

Countries

Japan

Contacts

Public ContactTamaki Furuhata

EP Mediate Co., Ltd. Foods Department, Trial Planning Section 1

furuhata.tamaki686@eps.co.jp070-3023-8207

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026