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Effects of Bifidobacterium on immune and gastrointestinal function - A Randomized, Double-blind, Placebo-controlled, Parallel-group Study -

Effects of Bifidobacterium on immune and gastrointestinal function - A Randomized, Double-blind, Placebo-controlled, Parallel-group Study - - Effects of Bifidobacterium on immune and gastrointestinal function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042392
Enrollment
100
Registered
2021-06-30
Start date
2021-01-14
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

Sponsors

DeNA Life Science, Inc
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy men and women over 50 years old 2. Subjects who have given written consent to participate in researches conducted by DeNA Life Science using samples and information obtained through MYCODE, the genetic testing service 3. Subjects who have be given sufficient explanation about the purpose and contents of this study, volunteer for voluntary participation with good understanding, and can consent to this examination in writing 4. Subjects who were considered appropriate to participate in this study by the study doctor

Exclusion criteria

Exclusion criteria: 1. Subjects who are receiving continuous pharmaceutical treatment 2. Subjects with previous and/or current medical history of serious disease (e.g. liver, kidney, heart, lung, blood) 3. Subjects with prevalence of digestive system comorbidities and previous medical history of the system 4. Subjects with serious anemia 5. Subjects with a risk of presenting allergic reaction to test capsule, other food, and medicine 6. Subjects who are taking medicine, supplement, and/or any food/functional food claiming an effect on immune function related evaluation items 7. Females who are pregnant and/or lactating, or those with willingness/intention to become pregnant during the study 8. Subjects that plan to have irregular life cycle (e.g. midnight shift work, long-term travel) and/or those with extremely irregular dining and sleep habits 9. Subjects with current or past (less than 3 months) experience of participating in other clinical studies (excluding non-invasive observational studies) 10. Subjects who are judged by the principal investigator to be unsuitable as the study

Design outcomes

Primary

MeasureTime frame
NK cell activity

Secondary

MeasureTime frame
Salivary secretion rate IgA concentration and secretion rate in saliva IgA concentration in feces Peripheral blood pDC activity Blood cytokine level(IFN-alpha2a, IFN-gamma, IL-6, IL-12, IL-18) Gut microbiota Profile of mood states Subjective sensation questionnaire Clinical symptoms (Online survey) Incidence rate of upper respiratory tract infection SNPs

Countries

Japan

Contacts

Public ContactTatsuya Matsuda

DeNA Life Science, Inc MYCODE service Dept

IRB_dis@dena.com03-4366-7219

Outcome results

None listed

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