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Study to Determine the Effects of Fermented Milk Drink on activated CD4+ T cells in Peripheral Blood Mononuclear Cells.

Study to Determine the Effects of Fermented Milk Drink on activated CD4+ T cells in Peripheral Blood Mononuclear Cells. - Study to Determine the Effects of Fermented Milk Drink on activated CD4+ T cells in Peripheral Blood Mononuclear Cells.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053525
Enrollment
10
Registered
2024-02-06
Start date
2024-01-19
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

Male/Female adults

Interventions

Consumption of a fermented milk drink (1 bottle a day) for 8 weeks.

Sponsors

Yakult Honsha Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Males and females aged 20 to below 60 years at the time of consent acquisition. 2. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.

Exclusion criteria

Exclusion criteria: 1. Subjects who experience abdominal symptoms (such as diarrhea, abdominal pain, bloating) upon consumption of dairy products. 2. Subjects who regularly use Food for Specified Health Uses (FOSHU), Foods with Function Claims, or health food (including supplements) more than twice a week, which may potentially affect the study and cannot discontinue them from the time of consent acquisition. 3. Subjects who are taking medications (such as antibiotics, Intestinal preparations, laxatives) more than twice a week, which may potentially affect the trial, and cannot restrict their use during the study period. 4. Subjects who excessive alcohol intake. 5. Subjects who smoke heavily (not less than 21 cigarettes a day) 6. Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.

Design outcomes

Primary

MeasureTime frame
Expression of activation markers on activated CD4+ T cells

Secondary

MeasureTime frame
1. Immune cell composition of Peripheral Blood Mononuclear Cells. 2. Immune-related markers in plasma. 3. Immune-related markers in feces. 4. Metabolites in feces. 5. Background questionnaire on daily life 6. Daily questionnaire on test drink and health condition.

Countries

Japan

Contacts

Public ContactTomoaki Naito

Yakult Honsha Co., Ltd. Yakult Central Institute

tomoaki-naito@yakult.co.jp042-577-8920

Outcome results

None listed

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