A study to evaluate the effects of lactic acid bacteria on menstrual symptoms

UMIN ID: UMIN000044933

Registered date:24/07/2021

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 2021/07/25
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake of test food for 3 menstrual cycles (11-13 weeks)
Intake of placebo for 3 menstrual cycles (11-13 weeks)

Outcome(s)

• Primary Outcome: MDQ (Menstrual Distress Questionnaire) score
• Secondary Outcome: VAS (Visual Analogue Scale) SF-36 (Medical Outcomes Study 36-Item Short-Form Health Survey) score Number of analgesic use

Key inclusion & exclusion criteria

• Age minimum: 25years-old
• Age maximum: 40years-old
• Gender: Female
• Exclude criteria: 1. Subjects who are pregnant or lactating, or intending to become pregnant during the study 2. Subjects who have histories of gynecologic disorder or have gynecologic disorder 3. Subjects with food allergies 4. Subjects who have diarrhea by intake of dairy products 5. Subjects who take regularly pharmaceuticals (including Chinese medicine and pill) or supplements which have the possibility to affect the results of the present study from 2 months before the time of informed consent to the day of informed consent 6. Subjects who take foods or drinks containing lactic acid bacteria (e.g. yoghurt) which have the possibility to affect the results of the present study 4 days or more a week 7. Subjects who had participated in other pharmaceutical or food clinical studies from 1 month before the time of informed consent to the day of informed consent 8. Subjects who often take analgesics for prophylactic purposes before having menstrual pain 9. Subjects whose MDQ score after menstruation is 1 or more points higher compared to the score of before or during menstruation at the first screening 10. Subjects with severe menstrual symptoms unable to be controlled by OTC analgesics 11. Subjects classified as psychosomatic (Type IV) by CMI health questionnaire 12. Subjects with a score of 20 or more for the stress score by Stress Check List 13. Subjects deemed unsuitable for the present study by the investigator

Related Information

• Primary Sponsor: Soiken Inc.
• Source(s) of Monetary Support: Meiji Co., Ltd.