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The Exploratory Study of the Effects of Continuous Intake of Foods Containing Lactic Acid Bacteria on Intestinal Barrier Function and Anti-inflammatory Effects

The Exploratory Study of the Effects of Continuous Intake of Foods Containing Lactic Acid Bacteria on Intestinal Barrier Function and Anti-inflammatory Effects - A Randomized, Single-Blind, Placebo-Controlled, Parallel Group Comparison Trial - - The Exploratory Study of the Effects of Continuous Intake of Foods Containing Lactic Acid Bacteria on Intestinal Barrier Function and Anti-inflammatory Effects - A Randomized, Single-Blind, Placebo-Controlled, Parallel Group Comparison Trial -

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058967
Enrollment
60
Registered
2025-09-04
Start date
2025-12-02
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

Take 100 g of test food containing lactic acid bacteria A once daily at any time for 12 weeks. Take 100 g of test food containing lactic acid bacteria B once daily at any time for 12 weeks. Take 100

Sponsors

Meiji Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese male and female aged 20 years or older and less than 65 years at the time of consent. 2. Subjects with a BMI of 18.5 kg/m2 or more and less than 25.0 kg/m2. 3. Subjects who have received sufficient explanation regarding the purpose and content of this study, have the capacity to consent, and voluntarily agree to participate after fully understanding the information.

Exclusion criteria

Exclusion criteria: Individuals who take Foods for Specified Health Uses, Foods with Function Claims, health foods, or certain general foods that may affect the study at least three times a week, or who cannot discontinue the intake of those from the time of consent. Individuals who have taken medications that may affect the study within two months prior to SCR1, or who plan to take such medications during the study period. Individuals who plan to undergo endoscopy, gastric barium examinations, or Helicobacter pylori eradication during the study period. Individuals who cannot refrain from alcohol from the day prior to each examination. Individuals with high alcohol consumption. Individuals who smoke or have not been abstine smoke for at least six months. Individuals with gastrointestinal diseases or with a history of gastrointestinal surgery that may affect digestion or absorption. Individuals who are taking medication for lifestyle-related diseases or other treatments. Individuals who are undergoing treatment at a medical institution or similar. Individuals with an irregular lifestyle. Individuals who plan to move, travel with an overnight stay of three nights or more after 1 week before the study food intake period. Individuals currently participating in clinical trials, those who plan to participate in other clinical trial within four weeks after the completion of the study or after obtaining consent to participate in the study. Individuals who are pregnant, breastfeeding, or intend to become pregnant during the study period. Individuals who are aware of or have been diagnosed with lactose intolerance or irritable bowel syndrome, or who experience excessive abdominal symptoms when consuming probiotics or prebiotics. Individuals with allergies to medications or foods. Individuals whose donated component blood or whole blood exceeds specified limit. Individuals who are deemed as inappropriate for participation in this study by the principal investigator or co-investigator.

Design outcomes

Primary

MeasureTime frame
Barrier and inflammatory indicators

Secondary

MeasureTime frame
Stool test Blood test Urine test Questionnaire on subjective symptoms Defecation status Safety of test foods

Countries

Japan

Contacts

Public ContactMakoto Ichinohe

CPCC Company Limited Clinical Planning Department

cpcc-contact@cpcc.co.jp03-6225-9001

Outcome results

None listed

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