UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048700 |
|---|---|
| Receipt number | R000055464 |
| Scientific Title | A study on the effect of continuous intake of test food containing Lactic acid bacteria on vaginal flora. |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/01/31 09:57:10 |
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Basic information
Public title
A study on the effect of continuous intake of test food containing Lactic acid bacteria on vaginal flora.
Acronym
A study on the effect of continuous intake of test food containing Lactic acid bacteria on vaginal flora.
Scientific Title
A study on the effect of continuous intake of test food containing Lactic acid bacteria on vaginal flora.
Scientific Title:Acronym
A study on the effect of continuous intake of test food containing Lactic acid bacteria on vaginal flora.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effectiveness of continuous intake of test food for 4 weeks on the vaginal flora and QOL in healthy females aged between 20 and 59.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nugent score
Key secondary outcomes
Vaginal Flora
pH
Questionnaire: QoL, defecation, Vaginal symptoms, pain, irritation, discomfort, feeling, concentration
Nugent score: subgroups divided by Nugent score at the screening
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take one capsule of test food with water or warm water once a day.
Interventions/Control_2
Take one capsule of placebo food with water or warm water once a day.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1. Aged between 20 and less than 60 years old at the time obtaining consent.
2. Japanese females.
3. Individuals who can receive vaginal speculum examination on the internal examination table.
4. Individuals who can input electric diaries using smart phones or PCs.
5. Individuals who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.
Key exclusion criteria
1. Individuals who are diagnosed as bacterial vaginosis in the past 3 months.
2. Individuals who currently are undergoing treatment for any disease, or receive medical treatment such as medical drugs or traditional Chinese medicines. Medications used as needed except antibiotics are acceptable.
3. Individuals whose menstrual cycles are unstable.
4. Individuals who regularly use intestinal regulators involving laxatives.
5. Individuals who received treatments involving oral medicines of antibiotics or Intravenous drip in the past 3 months.
6. Individuals who currently have or past had organic diseases concerning digestive system excluding oral cavity, esophagus, and stomach.
7. Individuals who currently have or past had severe diseases concerning liver, kidney, heart, respiratory system, endocrine, metabolism.
8. Individuals who did vaginal cleansing in the past 3 months.
9. Individuals who use intrauterine contraceptives.
10. Individuals who have currently been taking commercially available drugs, quasi-drug products, foods, or supplements with any functional claims.
11. Individuals who regularly take food mainly compounding lactate acid bacteria involving yogurt or lactic acid bacteria beverage.
12. Individuals who have used public pools containing chlorine, bath, or hot springs in the past 3 months.
13. Individuals who currently have or past had allergies to drugs or foods.
14. Individuals who take more than 60 g alcohol/day.
15. Individuals who are planning to extremely change lifestyle (such as diet, sleep, or exercise) during the study period.
16. Individuals who joined, have been joined, or are planning to join other clinical trials from one month before the trials.
17. Individuals who are currently pregnant or breastfeeding, or planning to pregnant during the study.
18. Individuals who are unsuitable for the study, that judged by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Harada |
Organization
The University of Tokyo
Division name
Faculty of Medicine, Department of Obstetrics and Gynecology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-6704-5968
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
07014357078
Homepage URL
sales-contact@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TEIJIN Ltd.
Yuhido inc.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.co.jp
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
| 2023 | Year | 02 | Month | 01 | 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
| 2022 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 19 | Day |
Last modified on
| 2023 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055464
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