A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of lactic acid bacteria on the immune function in healthy Japanese adult

A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of lactic acid bacteria on the immune function in healthy Japanese adult - A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of lactic acid bacteria on the immune function in healthy Japanese adult

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000045531

Enrollment

100

Registered

2021-09-21

Start date

2021-09-21

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 Japanese subjects

Interventions

The consumption of lactic acid bacteria powder for four weeks The consumption of placebo powder for four weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects aged 20 or more and less than 65

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a serious medical history of any disease such as malignant tumor, respiratory disease, liver, kidney, heart, lung, digestive organ, blood, endocrine system, or metabolic system 2. Subjects who have drug allergy and/or serious food allergy, or have medical history of them 3. Subjects who are pregnant, breast-feeding, and planning to become pregnant 4. Subjects who have autoimmune disease 5. Subjects who have used drugs which may influence immune function (including antiallergic drugs and antibiotics) at the period of screening, or take food containing specific bacteria such as bifidobacterium and lactic acid bacteria in daily 6. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 7. Subjects who have been taken 400 mL and more blood within 12 weeks before consumption of the test food, or 200 mL and more blood at the period of screening 8. Subjects who plan to receive vaccination for infectious diseases such as influenza or COVID-19 from after agreement to participate to the end of this trial 9. Subjects who are judged as ineligible to participate in the study based on the evaluation of the physician for any results such as participant' background, physical finding, consultation, physical examination, and clinical examination

Design outcomes

Primary

Measure	Time frame
The immune indicator (cell surface marker, neutrophil phagocytosis, neutrophil sterilizing function, NK cell activity, and cytokines)	—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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