UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effects of lactic acid bacteria on menstrual symptoms
Acronym	A study to evaluate the effects of lactic acid bacteria on menstrual symptoms
Scientific Title	A study to evaluate the effects of lactic acid bacteria on menstrual symptoms
Scientific Title:Acronym	A study to evaluate the effects of lactic acid bacteria on menstrual symptoms
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of lactic acid bacteria on menstrual symptoms in healthy adult females
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MDQ (Menstrual Distress Questionnaire) score
Key secondary outcomes	VAS (Visual Analogue Scale) SF-36 (Medical Outcomes Study 36-Item Short-Form Health Survey) score Number of analgesic use

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food for 3 menstrual cycles (11-13 weeks)
Interventions/Control_2	Intake of placebo for 3 menstrual cycles (11-13 weeks)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	25 years-old <=
Age-upper limit	40 years-old >
Gender	Female
Key inclusion criteria	1. Healthy adult females whose age of 25 years or more and less than 40 years (at the time of informed consent) 2. Subjects with 25 to 38 days menstrual cycle in the latest 6 menstruations and the menstrual duration is 3 to 7 days 3. Subjects with some menstrual symptoms before and during menstruation 4. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the present study and being able to sign a written informed consent
Key exclusion 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
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Toshihiro Middle name Last name Sashihara
Organization	Meiji Co., Ltd.
Division name	R&D Division
Zip code	192-0919
Address	1-29-1 Nanakuni, Hachioji, Tokyo
TEL	042-632-5842
Email	toshihiro.sashihara@meiji.com

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Sugino
Organization	Soiken Inc.
Division name	R&D Division
Zip code	560-0082
Address	Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	Meiji Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Fukuda Clinic
Address	Shin-Osaka brick building 2F, 1-6-1 Miyahara, Yodogawa-ku, Osaka, Osaka
Tel	06-6398-0203
Email	fukudaclinicIRB@gmail.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 06 Month 19 Day
Date of IRB	2021 Year 06 Month 19 Day
Anticipated trial start date	2021 Year 07 Month 25 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry	2022 Year 06 Month 21 Day
Date trial data considered complete	2022 Year 07 Month 07 Day
Date analysis concluded	2022 Year 08 Month 24 Day

Other
Other related information

Management information
Registered date	2021 Year 07 Month 21 Day
Last modified on	2022 Year 09 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051324