NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000044933

Registered date:24/07/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHealthy volunteers
Date of first enrollment2021/07/25
Target sample size80
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeMDQ (Menstrual Distress Questionnaire) score
Secondary OutcomeVAS (Visual Analogue Scale) SF-36 (Medical Outcomes Study 36-Item Short-Form Health Survey) score Number of analgesic use

Key inclusion & exclusion criteria

Age minimum25years-old
Age maximum40years-old
GenderFemale
Include criteria
Exclude criteria1. 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

Contact

public contact
Name Tomohiro Sugino
Address Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka Japan 560-0082
Telephone 06-6871-8888
E-mail sugino@soiken.com
Affiliation Soiken Inc. R&D Division
scientific contact
Name Toshihiro Sashihara
Address 1-29-1 Nanakuni, Hachioji, Tokyo Japan
Telephone 042-632-5842
E-mail toshihiro.sashihara@meiji.com
Affiliation Meiji Co., Ltd. R&D Division