UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044933 |
|---|---|
| Receipt number | R000051324 |
| Scientific Title | A study to evaluate the effects of lactic acid bacteria on menstrual symptoms |
| Date of disclosure of the study information | 2021/07/24 |
| Last modified on | 2022/09/30 11:33:07 |
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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
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
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051324
