Clinical Trial

Akkermansia Muciniphilia and Metabolic Side Effects of ADT

Recruiting Early Phase 1
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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 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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-03-24; most recent amendment 2025-08-15.
Status change: Not Yet Recruiting → Recruiting 2025-08-12
Trial Details
NCT Number NCT05802121
Lead Sponsor Western University
Conditions Prostate Cancer, Metabolic Syndrome, Obesity, Cardiovascular Morbidity, Bone Diseases, Hyperlipidemias, Diabetes
Enrollment 30 participants
Start Date 2025-07-02
Primary Completion 2026-09 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-08-20