Tokyo, Nov. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059873) titled 'An observational study investigating the characteristics of the vaginal microbiota in Japanese women' on Nov. 25.
Study Type:
Observational
Primary Sponsor:
Institute - Meiji Holdings Co., Ltd.
Condition:
Condition - N/A
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to investigate the association between the vaginal microbiota of healthy premenopausal adult women and host baseline characteristics.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - 1,Women aged 18 years or older at the time of consent
2,Premenopausal at the time of consent
3,Having received a sufficient explanation of the study, adequately understood it, and provided written informed consent of their own free will
Key exclusion criteria - 1.Women who are currently pregnant or may be pregnant
2.Women within six months postpartum
3.Women who have received oral or intravenous antibiotic therapy within the past two months
4.Women with a history of total hysterectomy or bilateral oophorectomy
5.Women who have a vaginal or uterine disease and are currently under treatment
6.Women who are under treatment for, or have a history of, malignant tumors, heart failure, or myocardial infarction
7.Women currently under treatment for any of the following chronic conditions: arrhythmia, liver dysfunction, chronic kidney disease, cerebrovascular disease, rheumatic disease, diabetes, dyslipidemia, hypertension, or other chronic diseases
8.Women with a colostomy
9.Women currently participating in another clinical study
10.Women otherwise deemed unsuitable as study participants by the principal investigator
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 14 Day
Date of IRB - 2025 Year 11 Month 14 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068472
Disclaimer: Curated by HT Syndication.