Actively Recruiting
Akkermansia Muciniphilia and Metabolic Side Effects of ADT
Led by Western University · Updated on 2025-08-20
30
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 a standard of care arm. 2. To confirm tolerability and assess for side effects of oral acetate supplementation. 2. Secondary outcomes: 1. To determine if increased counts of A. muciniphilia correlate with improved metabolic parameters and improved bone health.
CONDITIONS
Official Title
Akkermansia Muciniphilia and Metabolic Side Effects of ADT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men 18 years of age or older with confirmed metastatic castration-sensitive prostate adenocarcinoma planned to receive ADT
- Must have baseline imaging with CT of the abdomen and pelvis plus bone scan, or PSMA PET scan
You will not qualify if you...
- Age less than 18 years
- Primary neuroendocrine prostate cancer
- Treatment with ADT within the year before enrollment
- Planned or current use of chromium supplementation during the study
- Planned or current use of apple cider vinegar supplementation during the study
- Unable to provide informed consent or understand/read English without an interpreter
- Liver function greater than twice the upper limit of normal
- Any medical or lifestyle condition posing significant risk or affecting ability to complete the study
- Use of antibiotics that cannot be stopped for a washout period and during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada, N6A5W9
Actively Recruiting
Research Team
K
Kaydee Connors
CONTACT
S
Stephen Mardell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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