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NCT05802121
The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer
EARLY_PHASE1 trial testing Apple Cider Vinegar in Prostate Cancer in 30 participants. Currently enrolling.
1 September 2026
Quick facts
| Lead sponsor | Western University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 30 |
| Start date | 2 July 2025 |
| Primary completion | 1 September 2026 |
| Estimated completion | 1 June 2027 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Apple Cider Vinegar — full drug profile →
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
- Obesity — all drugs for Obesity →
- Cardiovascular Morbidity — all drugs for Cardiovascular Morbidity →
Sponsor
Western University
Who can join
18 and older, male only, with Prostate Cancer or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Fecal Akkermansia muciniphilia counts
Time frame: 1 week
Counts of Akkermansia muciniphilia in participant stool samples at 1 week following the intervention will be compared to baseline counts. -
Fecal Akkermansia muciniphilia counts
Time frame: 1 month
Counts of Akkermansia muciniphilia in participant stool samples at 1 month following the intervention will be compared to baseline counts. -
Fecal Akkermansia muciniphilia counts
Time frame: 3 month
Counts of Akkermansia muciniphilia in participant stool samples at 3 months following the intervention will be compared to baseline counts. -
Fecal Akkermansia muciniphilia counts
Time frame: 4 month
Counts of Akkermansia muciniphilia in participant stool samples at 4 months following the intervention will be compared to baseline counts. -
Fecal Akkermansia muciniphilia counts
Time frame: 6 month
Counts of Akkermansia muciniphilia in participant stool samples at 6 months following the intervention will be compared to baseline counts. -
Side effects and tolerability
Time frame: 3 months
We will record side effects reported by the participants and the rate of Discontinuation of the intervention.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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The Link Between the Gut Microbiome and Bone Metastasis.
Sevcikova A, Martiniakova M, Omelka R, Stevurkova V, et al · · 2024 · cited 5× · PMID 39596154 · DOI 10.3390/ijms252212086 -
The Role of Gut Microbiome in Prostate Cancer: Current Evidence and Emerging Opportunities.
Huang J, Zhu XH, Trotman LC, Tsao CK. · · 2026 · PMID 41899599 · DOI 10.3390/cancers18060998
Verify or expand the search:
- PubMed search for NCT05802121
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Apple Cider Vinegar
Trials testing the same drug.
- NCT07365956 — Comparison of Oral Care Solutions on Oral Microbial Colonization in Neurosurgical ICU Patients · NA · completed
- NCT04073719 — Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL) · NA · unknown
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
- NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
- NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
- NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
- NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
Other Western University trials
Trials by the same sponsor.
- NCT07402265 — Piloting a Brief, Online Intervention for Suicidality in Sexual and Gender Minority Youth · NA · not yet recruiting
- NCT06836921 — WECARE APD: Assessing a Single Multidisciplinary Team Visit for Atypical Parkinsonian Disorders · NA · not yet recruiting
- NCT04982978 — Information Interventions to Reduce Vaping in a Student Population · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05802121 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Western University
- Last refreshed: 15 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05802121.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing