A study for evaluating the effect of the intake of a lactic acid bacterium -containing food on salivary secretory immunoglobulin A (sIgA) and fatigue : a randomized, double blind, placebo-controlled, parallel-group trial

A study for evaluating the effect of the intake of a lactic acid bacterium -containing food on salivary secretory immunoglobulin A (sIgA) and fatigue : a randomized, double blind, placebo-controlled, parallel-group trial - A study for evaluating the effect of the intake of a lactic acid bacterium -containing food on salivary secretory immunoglobulin A (sIgA) and fatigue

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022880

Enrollment

Registered

2017-04-01

Start date

2016-06-26

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 a lactic acid bacterium for 12 consecutive weeks Ingestion of placebo without a lactic acid bacterium for 12 consecutive weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Males and females from 20 to 64 years of age 2) Lower salivary secretory immunoglobulin A secretion rate 3) POMS2-AS FI T score : >= 50 and VA T score : <= 50

Exclusion criteria

Exclusion criteria: 1) Subjects that regularly consume food rich in lactic acid bacteria more than 3 times a week 2) Subjects with regular consumption of lactic acid bacteria -fortified food or lactic acid bacteria preparation 3) Subjects that regularly consume dietary supplements which may influence immune function 4) Subjects with history of the allergic disease 5) Subjects undergoing medical treatment which may influence the outcome of the study (e.g., hyposensitization) 6) Subjects who have received oral or dental treatment from one month before the screening tests or intend to receive oral or dental care during the study 7) Subjects with oral or dental problems (e.g., stomatitis, oral mucosal bleeding) or develop them more than once a week 8) Subjects with regular bleeding gums during brushing 9) Night and day shift worker or manual laborer 10) Subjects with intensive physical activity (e.g., marathon race) 11) Subjects with poor adherence to the measurement procedures 12) Subjects undergoing medical treatment or require medical treatment 13) Subjects with severe diseases (e.g., diabetes, liver disease, kidney disease, or heart disease) and diseases that may affect the adrenal cortical hormone secretion 14) Subjects potentially allergic to contents in test food such as lactic acid bacteria 15) Subjects who are judged inappropriate for the study according to the results of screening tests 16) Subjects who intend to become pregnant during the study period or being pregnant or lactating 17) Subjects who have participated in other clinical studies within one month from obtaining informed consent or intend to participate in other clinical studies after obtaining informed consent 18) Subjects who are judged inappropriate for the study according to the results of lifestyle questionnaire 19) Subjects who are judged inappropriate for the study by the physician

Design outcomes

Primary

Measure	Time frame
salivary sIgA secretion rate	—

Secondary

Measure	Time frame
salivary sIgA concentration, POMS2	—

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