A placebo-controlled, double-blind, randomized, comparative superiority trial concerning subjective physical symptoms effected by taking lactic acid bacteria in healthy adults.

A placebo-controlled, double-blind, randomized, comparative superiority trial concerning subjective physical symptoms effected by taking lactic acid bacteria in healthy adults. - A placebo-controlled, double-blind, randomized, comparative superiority trial concerning subjective physical symptoms effected by taking lactic acid bacteria in healthy adults.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000051260

Enrollment

200

Registered

2023-07-14

Start date

2023-07-15

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

In principal take one pack of the test food per day for 16 weeks. In principal take one pack of the placebo food per day for 16 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and less than 65 years old at the date of the consent obtained. 2. Those who have no problems operating PCs and smartphones.

Exclusion criteria

Exclusion criteria: 1. Those who are undergoing treatment for malignant tumor, respiratory disease, liver, kidney, heart, lung, digestive system, blood, endocrine system, metabolic system, etc., or those who have a serious history of these. 2. Those who have or have a history of drug allergies or serious food allergies. 3. Those who are pregnant or breastfeeding, or willing to be pregnant during the trial period. 4. Those who have autoimmune diseases. 5. Alcohol drinking over 40g/day (nearly equal to 2 medium-sized beer bottles) more than 3 days per a week. 6. Those who use drugs that are thought to affect immune function including antiallergic drugs and antibiotics, or who regularly use foods containing specific bifidobacteria, lactic acid bacteria, etc. However, those who can stop after obtaining consent can participate. 7. Those who have participated in other clinical trials within 4 weeks before the date of the consent obtained, or those who plan to participate during the trial period. 8. Those who have collected 400 mL or more of blood within 4 weeks before the consent obtained, or 200 mL or more of blood was collected before the date of pre-intake examination after the consent obtained. 9. Those who have been vaccinated against infectious diseases such as influenza and novel coronavirus within 4 weeks before the day of the pre-ingestion inspection. 10. Those who are judged by the investigator to be unsuitable as a study participant based on the results of study participant background, physical findings, medical examination, physical examination, clinical examination, etc.

Design outcomes

Primary

Measure	Time frame
Subjective symptoms related to physical condition	—

Secondary

Measure	Time frame
Immunological functions	—

Countries

Japan

Contacts

Public ContactHirokuni Kayama

IMEQRD Co., Ltd Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

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