Prostate cancer
Conditions
Interventions
Control group:Oral placebo
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically confirmed prostate cancer and planning to undergo radiotherapy; 2. Age 40-85 years old; 3. Those who are expected to survive for more than 12 months; 4. Volunteer to participate in this experiment and sign the informed consent form, and can cooperate with sampling and follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who have used antibiotics, proton pump inhibitors, probiotics, prebiotics and prebiotics and other drugs and preparations that affect intestinal microbes within 4 weeks; 2. Active infection within 12 weeks, including mycobacterial infection, opportunistic infection, etc.; Those who are combined with intestinal perforation, intestinal obstruction, sepsis and other diseases; 3. Chronic infectious diseases that are active: such as chronic hepatitis B, AIDS, or tuberculosis; 4. Patients with recurrent colitis and proctitis (more than 1 time/month), Crohn's disease, ulcerative coloritis, and diarrhea (4 times or more) before radiotherapy; 5. Diagnosis of other malignant tumors within 2 years, tumors are not controlled; 6. Those with serious diseases of other organs; 7. Those with severe allergies; 8. Long-term use of immunosuppressants or concomitant use of immunostimulants after organ transplantation; 9. Those who have participated in any drug clinical trial (as subjects) within 12 weeks before screening and have received drug intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diarrhea grade; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time and frequency of antidiarrheal drug administration;LENT-SOMA score;Complete blood test;Blood biochemistry;Lymphocyte subsets;Intestinal microbiota;oral microbiota;12-plex cytokine panel;antioxidant indicators; | — |
Countries
China
Contacts
Public ContactLi Hongzhen
Peking University First Hospital
Outcome results
None listed