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A preliminary study on the effect of a lactic acid bacteria intake on immune function. -a open-label, single-arm trial-

A preliminary study on the effect of a lactic acid bacteria intake on immune function. -a open-label, single-arm trial- - A preliminary study on the effect of a lactic acid bacteria intake on immune function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046586
Enrollment
20
Registered
2022-01-19
Start date
2022-01-21
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 adults

Interventions

Take one capsule of the test food with water or warm water within 30 min after dinner once a day.

Sponsors

IMEQRD Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 40 and less than 65 years old. 2. Japanese males and females. 3. Individuals who contract the common cold between winter and spring every year. 4. BMI between 18.5 kg/m^2 and less than 30.0 kg/m^2. 5. Individuals who can use smartphones or PCs to input an electronic diary. 6. Individuals who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.

Exclusion criteria

Exclusion criteria: 1. Individuals who have mouth dryness, or Sjogren's syndrome. 2. Individuals who are currently undergoing treatment for any disease. 3. Individuals who have been receiving nutritional and exercise therapy under medical doctor's management. 4. Individuals who have severe diseases or a history of severe diseases. 5. Individuals who have allergic dermatitis, allergic rhinitis, bronchial asthma, or chronic bronchitis. 6. Individuals who have currently been taking commercially available drugs, quasi-drug products, and foods, drinks, or supplements with any functional claims. 7. Individuals who have been taking yogurts, beverages, health foods, supplements which include lactic acid bacteria and/or Bifidobacterium. 8. Individuals who have a drug allergy, or a food allergy. 9. Individuals who are currently pregnant or breastfeeding, or planning to pregnant during the study period. 10. Individuals who work in shift and night shift. 11. Individuals who are planning travel to foreign countries during the study period. 12. Individuals who drink more than 60 g alcohol/day. 13. Individuals who have been vaccinated to protect against infectious diseases, such as influenza virus or SARS-CoV-2, one month before the screening period. Also, individuals who are planning vaccination during the study period. 14. Individuals who are planning extremely change their lifestyle (such as diet, sleep, or exercise) during the study period. 15. Individuals who joined other clinical trials from one month before obtaining informed consent in this study, or individuals who have currently been joined other clinical trials. Also, individuals who are planning to join other clinical trials. 16. Individuals who are unsuitable for this study, that judged by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Immune function-related markers Questionnaire for physical health Questionnaire for fatigue assessment

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co., Ltd. Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

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