Investigating bowel bacteria changes in prostate cancer patients undergoing radiotherapy
Chronic Radiation Induced Bowel Toxicity Study (CRIBS)
This study is trying to see how the bacteria in the stool of prostate cancer patients change during and after pelvic radiotherapy and how these changes relate to their health and diet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | The Christie NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (Manchester, Greater Manchester and 1 other locations) |
| Trial ID | NCT06640959 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the bacteria present in the stool of patients with prostate cancer who are undergoing pelvic radiotherapy. The researchers will collect stool, blood, urine, and optional rectal swab samples at various points during and after treatment to assess any changes in the microbiota and related immunological responses. Additionally, participants will complete food diaries and health questionnaires to provide further insights into their dietary habits and quality of life. The study will recruit approximately 50 patients across two sites over a two-year period.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older with newly diagnosed, localized, intermediate to high-risk prostate cancer scheduled for radical radiotherapy.
Not a fit: Patients who have received recent antibiotics, cytotoxic therapies, or have certain gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of bowel toxicity related to radiotherapy and potentially improve patient management strategies.
How similar studies have performed: While similar studies have explored the microbiota in cancer treatment, this specific approach focusing on radiation-induced changes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male, aged ≥ 18; no upper age limit and able to give informed consent. * Newly diagnosed patients with, histologically confirmed, localised, intermediate to high-risk prostate cancer (T2b -T4a N0 M0). * Patients to be treated with prostate radical radiotherapy IMRT (60Gy in 20# with curative intent) 4-week regimen. * Performance status - ECOG 0-2. Exclusion Criteria: * Had received systemic antibiotics (intravenous, intramuscular, or oral) within 2 months before enrolment. * Had received cytotoxic or immunosuppressive therapies within 6 months of enrolment, including chemotherapy or immunotherapy. * Had consumed large doses of commercial probiotics (greater or equal to 108 CFU per day) within 12 months of enrolment (such as Actimint®, CranProBio®, ImmunoProBio®, among others). * Patients with diagnosed inflammatory bowel disease or coeliac disease * Patients with previous colorectal cancer * Patients who have undergone colectomy (total or subtotal) * Patients with a history of diverticulitis (uncomplicated diverticular disease permitted)
Where this trial is running
Manchester, Greater Manchester and 1 other locations
- Christie NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (Recruiting)
- Lancashire Teaching Hospitals NHS Foundation Trust — Preston, Lancashire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Lois Gardner, PhD
- Email: lois.gardner@manchester.ac.uk
- Phone: 01612008863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.