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Evaluation of Gut Microbiome in Patients With Prostate Cancer

Analysis of Gut Microbiome in Prostate Cancer Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03709485
Enrollment
150
Registered
2018-10-17
Start date
2018-11-01
Completion date
2019-12-30
Last updated
2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

microbiome, prostate cancer, sequencing

Brief summary

The research will focus on the possible connection between prostate cancer, and various species of bacteria in the large intestine. In consecutive patients, referred to prostate biopsies, rectal swabs will be taken before the biopsies and before antibiotic treatment. The gut flora will be examined and characterized by a microbiome analysis tool. Negative patients will serve as internal control. The investigators will look for association between prostate cancer of various grades and the presence of specific enteropathogens in the rectal flora of the participants.

Detailed description

Prostate cancer is the no. 1 cancer among men. Risk factors include Afro-American origin, prostate cancer in a first degree relatives and the presence of BRCA2 genetic mutations. No specific association has been described yet between prostate cancer and specific gut bacteria. The GI tract is the home of billions of bacteria. The microbiome functions as a separate organ and contains 10 times the amount of genes compared to the human genome. The microbiome has crucial impact on the human metabolism, inflammatory processes and filtration of GI content. All of these effects may contribute to the exposure of the human body to various carcinogens and inflammatory factors, leading eventually to the development of cancer in remote organs. The purpose of this research is to try and identify specific species that might be related to the development of prostate cancer.

Interventions

OTHERrectal swab for microbial culture.

Rectal swab and culture.

Sponsors

Ziv Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* male gender * age above 45 * referred for prostate biopsy

Exclusion criteria

* age below 45 * antimicrobial therapy in the 7 days prior to biopsy * previous prostate or pelvic irradiation * patients who suffer from inflammatory bowel disease * systemic chemotherapy for any reason in the 3 months prior to the biopsy.

Design outcomes

Primary

MeasureTime frameDescription
Characterization of gut microbiome1 yearAnalysis of rectal swab cultures.
Association of prostate cancer patients and specific microbes.1 yearRelationship between patients with prostate cancer and specific strains of rectal microbes

Contacts

Primary ContactRan Katz, MD
ran.k@ziv.health.gov.il+972-4-6828775
Backup ContactTalia Simchi
Tali.s@ziv.health.gov.il+972-4-6828775

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026