Analysis of Gut Microbiome in Prostate Cancer Patients
| Registry | NCT03709485 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, basic science |
| Enrollment | 150 (Estimated) |
| Sponsor | Ziv Hospital (Other gov) |
| Conditions | Prostate Cancer |
| Interventions | rectal swab for microbial culture. (Other) |
| Dates | start 2018-11-01 (estimated), primary completion 2019-11-01 (estimated), completion 2019-12-30 (estimated), first posted 2018-10-17, last updated 2018-10-17 |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Prostate Cancer All trials of rectal swab for microbial culture.
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| prostate biopsy patients | Experimental | Other: rectal swab for microbial culture. | a cohort o consecutive patients referred to prostate biopsies. In all patients, a rectal swab will be taken prior to biopsy and antimicrobial treatment. The swab will be cultured and analyzed in the lab for characterization of the microbiome. |
Sex: Male, ages: 45 Years to any
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.