Raising gut Akkermansia muciniphila with oral acetate (apple cider vinegar) during androgen deprivation therapy
The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer
This tests whether taking oral acetate (apple cider vinegar) can raise Akkermansia muciniphila levels in the gut and help metabolic and bone health in men starting androgen deprivation therapy for metastatic castration‑sensitive prostate cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Western University Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT05802121 on ClinicalTrials.gov |
What this trial studies
This early-phase 1 interventional trial gives oral acetate (as apple cider vinegar) to men with metastatic castration‑sensitive prostate cancer who are starting androgen deprivation therapy and compares them to a standard-of-care arm. The primary aims are to confirm that acetate increases the proportion of Akkermansia muciniphila in stool and to record tolerability and side effects. Secondary outcomes examine whether increased A. muciniphila counts correlate with improvements in metabolic measures and bone health. Enrollment requires baseline imaging and excludes recent ADT, primary neuroendocrine tumors, significant liver dysfunction, and concurrent apple cider vinegar or chromium supplementation.
Who should consider this trial
Good fit: Men aged 18 or older with histologically confirmed metastatic castration‑sensitive prostate adenocarcinoma who are about to start ADT, can complete required baseline imaging, and can provide informed consent are the intended participants.
Not a fit: Patients with primary neuroendocrine prostate cancer, ADT within the past year, significant liver dysfunction, planned or concurrent apple cider vinegar or chromium use, or inability to consent or comply are unlikely to be eligible or receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this could offer a simple, low-cost approach to boost a beneficial gut microbe and reduce metabolic and bone complications from androgen deprivation therapy.
How similar studies have performed: Early human and preclinical work has linked higher A. muciniphila or acetate exposure to better metabolic markers, but using oral acetate to boost A. muciniphila specifically in prostate cancer patients on ADT is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
For inclusion in this study, patients must fulfill all of the following criteria: 1. Men ≥18 years of age with histologically-proven metastatic castration-sensitive prostate adenocarcinoma planned to receive ADT (TNM stage Tany, Nany, M1) (see Appendix I). 2. Must have baseline imaging with 1) CT of the abdomen, and pelvis and bone scan or 2) PSMA PET scan Patients fulfilling any of the following criteria are NOT eligible for participation in this study: 1. Age less than 18 2. Primary neuroendocrine prostate cancer 3. Treatment with ADT within the year leading up to enrolment 4. Planned or concurrent use of chromium supplementation for the study duration 5. Planned or concurrent use of apple cider vinegar supplementation for the study duration 6. Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter) 7. Inadequate liver function (\>2x upper limit of normal) 8. Any other condition, chronic disease, or lifestyle factor, that, in the opinion of the Qualified Investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant 9. Use of antibiotics that cannot be discontinued for a washout period and remain off them for the duration of the trial
Where this trial is running
London, Ontario
- London Health Sciences Centre - Victoria Hospital — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Melissa Huynh, MD — Western University
- Study coordinator: Kaydee Connors
- Email: kaydee.connors@lhsc.on.ca
- Phone: 519-685-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.