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A study for evaluating the effect of the intake of a lactobacillus-containing food on immune system in adults with lower salivary secretory immunoglobulin A (s-IgA) secretion rate : randomized, placebo-controlled, double blind trial

A study for evaluating the effect of the intake of a lactobacillus-containing food on immune system in adults with lower salivary secretory immunoglobulin A (s-IgA) secretion rate : randomized, placebo-controlled, double blind trial - A study for evaluating the effect of the intake of a lactobacillus-containing powder on immune system in adults with lower salivary secretory immunoglobulin A (s-IgA) secretion rate

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018423
Enrollment
60
Registered
2016-06-01
Start date
2015-07-26
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

Ingestion of test food containing lactobacillus for 12 consecutive weeks Ingestion of placebo without lactobacillus for 12 consecutive weeks

Sponsors

TTC Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Males and females from 20 to 64 years of age 2) A lower salivary secretory immunoglobulin A secretion rate

Exclusion criteria

Exclusion criteria: 1) Subjects who routinely use (more than 3 times a week) food or medicine containing of lactobacillus 2) Subjects routinely taking dietary supplements which may influence immune function 3) Subjects who has history of the allergic disease 4) Subjects who are under medication which may influence the outcome of the study (e.g., hyposensitization) 5) Subjects who are have treated oral or dental care within the last one month prior to the current study or are planned to treat oral or dental care 6) Subjects who has oral or dental problems with bleeding 7) Night and day shift worker or manual laborer 8) Subjects who has carries out an intense activity (e.g., marathon race) 9) Subjects who cannot carry out a procedure of various inspection by the rule during the study period 10) Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor 11) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion 12) Subjects having possibilities for emerging allergy related to the study 13) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 14) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating 15) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 16) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 17) Subjects who are judged as unsuitable for the study by the investigator for other reason

Design outcomes

Primary

MeasureTime frame
Salivary s-IgA secretion rate

Secondary

MeasureTime frame
Salivary s-IgA concentration

Countries

Japan

Contacts

Public ContactHiroyasu Shimada

TTC Co., Ltd. Clinical Research Planning Department

h.shimada@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

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