Raising gut Akkermansia muciniphila with oral acetate (apple cider vinegar) during androgen deprivation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.