Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573827
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
The Urinary Microbiome and Its Relationship to the Urinary and Serum Metabolome in Healthy Peri- and Postmenopausal Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Urinary Microbiome and Its Relationship to the Urinary and Serum Metabolome in Healthy Peri- and Postmenopausal Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The presented project aims to characterize the microbiome of healthy peri- and postmenopausal women and its correlation with the metabolome of urine and serum
Detailed Description:
At the beginning of their visit to the Blood Center of the University Hospital Ostrava blood and plasma donors will be approached by one of the authorized members of the team with information about the possibility of participating in this study The course of the study will be explained to them in detail including the sampling methodology their processing and further handling If the subject is interested in participating in the study they will give written informed consent to participate in the study Subsequently the inclusion and exclusion criteria for participation in the study will be verified If these are not met the subject will be excluded from the study Furthermore the criteria for current valid blood and urine sampling will be verified If the conditions for valid sampling are not met and the participant is still interested in participating in the study she will be offered a new sampling date If the study subject fulfills the conditions of valid sampling she will fill out a simple questionnaire which will be used to obtain data on basic demographic characteristics Their knowledge is essential for the correct interpretation of urine and serum test results Blood and serum will then be collected In justified cases sampling can also be carried out at the Urology Department of the University Hospital Ostrava After submitting the first sample the participant will be asked to submit another urine and serum sample in 3-6 months By submitting the 2nd urine and serum sample the participant ends her participation in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None