RecruitingEarly Phase 1NCT05802121

Akkermansia Muciniphilia and Metabolic Side Effects of ADT

The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer


Sponsor

Western University

Enrollment

30 participants

Start Date

Jul 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a probiotic supplement containing a specific beneficial gut bacterium (Akkermansia muciniphila) can reduce metabolic side effects — such as weight gain, blood sugar problems, and changes in cholesterol — in men with prostate cancer who are receiving hormone-blocking therapy (ADT). **You may be eligible if:** - You are a man aged 18 or older - You have metastatic prostate cancer (cancer has spread beyond the prostate) confirmed by biopsy - You are about to start hormone-blocking therapy (ADT) for the first time - You have recent imaging (CT scan and bone scan, or PSMA PET scan) - You are able to give informed consent in English (or with an interpreter) **You may NOT be eligible if:** - You have already received ADT within the past year - You have neuroendocrine (a rare, aggressive type) prostate cancer - You are taking chromium or apple cider vinegar supplements and cannot stop - You need antibiotics you cannot stop for the duration of the study - Your liver function is significantly impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApple Cider Vinegar

Each patient will be instructed to take 1 caplet (equivalent of 143 mg/caplet containing 36% acetic acid) per day for 3 months (NPN: 80078433) https://www.jamiesonvitamins.com/products/apple-cider-vinegar-chromium?srsltid=AfmBOoqdVBFe83\_5JM9BmkomQM1LqsJYSFTiP\_78cnmehfzVg-4T4Z6o


Locations(1)

London Health Sciences Centre - Victoria Hospital

London, Ontario, Canada

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NCT05802121


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