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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045564
Enrollment
100
Registered
2021-09-26
Start date
2021-09-27
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

None

Interventions

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy male/female subjects Healthy male/female subjects aged more than 20 years, less than 65 years. (2) Subjects who can give informed consent to take part in this study, after being provided with an explanation of the protocol detail.

Exclusion criteria

Exclusion criteria: (1) Subjects who are under some kind of continuous medical treatment for malignant tumor, respiratory disease, liver, kidney, heart, lung, digestive organ, blood, endocrine/metabolic system, etc., or have a previous medical history of related serious diseases. (2) Subjects who have drug allergy or severe food one, and/or a previous medical history of those. (3) Pregnant, possibly pregnant, and lactating women. (4) Subjects who are affected by an autoimmune disease. (5) Subjects who have excessive alcoholic drinks. (6) Subjects who are equipped with lactose intolerance constitutionally. (7) Subjects who will take medicine (e.g., antiallergics and antibiotics) during the screening test period, which might affect their immune function, or are taking a specified food containing bifidobacteria, lactic acid bacteria, and so on. (8) Subjects who took part in another clinical study within 28 days before giving informed consent to participate in this study, or are planning to take part in another one during this study. (9) Subjects who donated 400 mL of their blood within twelve weeks before the beginning of test-food intakes, or not less than 200 mL of their blood during the screening test period. (10) Subjects who were vaccinated against pandemics such as influenza, novel coronavirus, etc., within a month before prior examination, or are planning to vaccinate them against those viruses before the completion of this study. (11) Others who have been determined as ineligible for the research subject of this study, judging from the principal/sub investigator's opinions on the findings of their background, physical observations, medical checkup, physical/clinical examination, and so on.

Design outcomes

Primary

MeasureTime frame
Cell surface marker

Secondary

MeasureTime frame
1. Neutrophilic phagocytosis 2. Neutrophilic bactericidal ability 3. NK cell activity 4. Cytokines (INF-alpha, INF-beta, INF-gamma, IL-6, IL-12, etc.)

Countries

Japan

Contacts

Public ContactMasanori Numa

CPCC Company Limited Clinical Planning Department

cpcc-contact@cpcc.co.jp03-5297-3112

Outcome results

None listed

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