Confirmation test for the effect of milk-derived protein intake on improving the vaginal environment

UMIN ID: UMIN000057039

Registered date:16/02/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2025/03/25
• Target sample size: 72
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingestion of test food for 8 weeks
Ingestion of placebo food for 8 weeks

Outcome(s)

• Primary Outcome: Nugent score Visual Analogue Scale
• Secondary Outcome: Safety (adverse events, body measurements, physical examinations, clinical tests)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 49years-old
• Gender: Female
• Exclude criteria: (1) Subjects with bacterial vaginosis and sexually transmitted infections. (2) Subjects with a history of diabetes, liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease. (3) Subjects with gynecological diseases (such as endometriosis, uterine fibroids, ovarian cysts, cervical cancer, uterine cancer, etc.) and a history of such conditions. (4) Subjects who have undergone gastrointestinal surgery (5) Subjects with abnormal liver and renal function test values (6) Subjects with diseases currently being treated (7) Subjects who are allergic to food and drugs (8) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects (9) Subjects who play intense sports and subjects who are on a diet (10) Subjects with extremely irregular eating habits s (11) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (12) Subjects using products or drugs that affect hormone balance (13) Subjects receiving antibiotics (14) Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs) (15) Subjects who drink more than 40 g of pure alcohol per day (16) Subjects who cannot abstain from alcohol from the day before the test to the day of the test (17) Subjects who smoke an average of more than 21 cigarettes per day. (18) Subjects who are participating in or will participate in other clinical trials at the start of this study (19) Other subjects judged by the investigator or the investigator to be inappropriate for the examination

Related Information

• Primary Sponsor: Miura Clinic, Medical Corporation Kanonkai
• Source(s) of Monetary Support: NRL Pharma, Inc.