Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05802121
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-06
First Post:
2023-03-12
Brief Title:
Akkermansia Muciniphilia and Metabolic Side Effects of ADT
Sponsor:
Western University
Organization:
Western University
Study Overview
Official Title:
The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overriding objectives of this study are
1 Primary outcomes
1 To confirm that administration of oral acetate increases the proportion of A muciniphilia in the stool samples of patients with metastatic castration-sensitive prostate cancer compared to placebo
2 To confirm tolerability and assess for side effects of delayed oral acetate supplementation
2 Secondary outcomes
1 To determine if increased counts of A muciniphilia correlate with improved metabolic parameters and improved bone health
1 Primary outcomes
1 To confirm that administration of oral acetate increases the proportion of A muciniphilia in the stool samples of patients with metastatic castration-sensitive prostate cancer compared to placebo
2 To confirm tolerability and assess for side effects of delayed oral acetate supplementation
2 Secondary outcomes
1 To determine if increased counts of A muciniphilia correlate with improved metabolic parameters and improved bone health
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None